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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Scissors, General, Surgical
510(k) Number K900950
Device Name GS-2000 MICRO SCISSOR, CURVED LEFT, 5MM
Applicant
Solos Endoscopy, Inc.
6191 Atlantic Blvd. Suite 4
Norcross,  GA  30071
Applicant Contact LEILA H HOLMES
Correspondent
Solos Endoscopy, Inc.
6191 Atlantic Blvd. Suite 4
Norcross,  GA  30071
Correspondent Contact LEILA H HOLMES
Regulation Number878.4800
Classification Product Code
LRW  
Date Received02/27/1990
Decision Date 04/18/1990
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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