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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pad, eye
510(k) Number K781539
Device Name ISO-CARE KIT
Applicant
NICE-PAK PRODUCTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
NICE-PAK PRODUCTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4440
Classification Product Code
HMP  
Date Received09/08/1978
Decision Date 11/03/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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