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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal
510(k) Number K971075
Device Name PRIMED PRIME-PLUS COTTON GAUZE SPONGES
Applicant
Primeline Medical Products, Inc.
2235-27th Ave., NE
Calgary
Alberta,  CA T2E 7M4
Applicant Contact GUY PLAMONDON
Correspondent
Primeline Medical Products, Inc.
2235-27th Ave., NE
Calgary
Alberta,  CA T2E 7M4
Correspondent Contact GUY PLAMONDON
Classification Product Code
EFQ  
Date Received03/24/1997
Decision Date 06/22/1997
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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