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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K933683
Device Name PENTAX FACE MASK
Applicant
Pentax Precision Instrument Corp.
30 Ramland Rd.
Orangeburg,  NY  10962
Applicant Contact NANAMI V NOMIYAMA
Correspondent
Pentax Precision Instrument Corp.
30 Ramland Rd.
Orangeburg,  NY  10962
Correspondent Contact NANAMI V NOMIYAMA
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/29/1993
Decision Date 06/02/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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