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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,Nonresorbable For External Use
510(k) Number K870282
Device Name 4 X 4 SPONGES, NON-STERILE
Applicant
The Medical Group, Inc.
4600 Kietzke Ln. L235
Reno,  NV  89502
Applicant Contact SCOTT J PYPER
Correspondent
The Medical Group, Inc.
4600 Kietzke Ln. L235
Reno,  NV  89502
Correspondent Contact SCOTT J PYPER
Regulation Number878.4014
Classification Product Code
NAB  
Date Received01/27/1987
Decision Date 02/24/1987
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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