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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 K962654
Device Name COMPLEAT SURGICAL MASK
Applicant
Carl Parker Associates, Inc.
275 Oser Ave.
Hauppauge,  NY  11788
Applicant Contact ANDREW PARKER
Correspondent
Carl Parker Associates, Inc.
275 Oser Ave.
Hauppauge,  NY  11788
Correspondent Contact ANDREW PARKER
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/08/1996
Decision Date 01/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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