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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 K863760
Device Name 2X2 SPONGES, NON-STERILE
Applicant
The Medical Group, Inc.
4600 Kietzke Ln. L235
Reno,  NV  89502
Applicant Contact CHUCK SMITHSON
Correspondent
The Medical Group, Inc.
4600 Kietzke Ln. L235
Reno,  NV  89502
Correspondent Contact CHUCK SMITHSON
Classification Product Code
EFQ  
Date Received09/25/1986
Decision Date 10/24/1986
Decision Substantially Equivalent (SESE)
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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