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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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purilens saline solution Purilens, Inc. k002319 08/30/2000
senstouch powder free examination gloves, non sterile Pt Mahakarya Inti Buana k061233 11/03/2006
prosomnus [ca] sleep and snore device and prosomnus [ca] sleep and snore device with micro-recorder Prosomnous Sleep Technologies k172859 11/22/2017
easistim Promed Corp. k861091 06/02/1986
scented menstrual pads Procter & Gamble Mfg. Co. k811868 07/16/1981
aquanet, model ec 2000 Prime Pacific Health Innovations Corporation k000031 09/10/2001
barron twin blade trephine for eppikaratophakia Precision Instruments, Inc. k860648 03/25/1986
disposable pvc examination glove, powdered and powder-free Practical Protective Plastic Manufactory , Ltd. k053259 01/18/2006
airray-mini 80a, airray-mini 90a, airray-mini 80f, airray-mini 90f (airray-mini) Poskom Co., Ltd. k253244 02/23/2026
polywin safety (14g x 51mm; 16g x 51mm; 18g x 64mm; 20g x 64mm; 20g x 45mm; 22g x 64mm; 22g x 45mm; 24g x 32mm; 24g x 14mm, 26g x 14mm); polywin safety adva (20g x 45mm; 22g x 64mm; 22g x 45mm ; 24g x 32 mm; 24g x 14mm; 14g x 51mm; 16g x 51mm; 18g x 64mm; 20g x 64mm, 26g x 14mm) Poly Medicure Limited k252513 04/01/2026

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