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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burr, Corneal, Battery-Powered
510(k) Number K942636
Device Name PSB PREPERITONEAL STRUCTURE BALLOON
Applicant
ORIGIN MEDSYSTEMS, INC.
135 CONSTITUTION DR.
MENLO PARK,  CA  94025
Applicant Contact JILL SCHWEIGER
Correspondent
ORIGIN MEDSYSTEMS, INC.
135 CONSTITUTION DR.
MENLO PARK,  CA  94025
Correspondent Contact JILL SCHWEIGER
Regulation Number886.4070
Classification Product Code
HOG  
Date Received06/03/1994
Decision Date 07/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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