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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K922917
Device Name ENDOPROBES
Applicant
Endooptiks, Inc.
28 Marigold Ln.
Marlboro,  NJ  07746
Applicant Contact MARTIN S KNOPF
Correspondent
Endooptiks, Inc.
28 Marigold Ln.
Marlboro,  NJ  07746
Correspondent Contact MARTIN S KNOPF
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/17/1992
Decision Date 09/28/1992
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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