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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blade, Scalpel
510(k) Number K873493
Device Name NINJA SCALPEL
Applicant
Primrose Medical, Inc.
20 Cabot Rd.
Woburn,  MA  01801
Applicant Contact FLETCHER LONGLEY
Correspondent
Primrose Medical, Inc.
20 Cabot Rd.
Woburn,  MA  01801
Correspondent Contact FLETCHER LONGLEY
Regulation Number878.4800
Classification Product Code
GES  
Date Received08/31/1987
Decision Date 09/24/1987
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
Predetermined Change
Control Plan Authorized		 No
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