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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, cryophthalmic
510(k) Number K870195
Device Name UNITED SURGICAL CORP. CRYOPTIC PLUS
Applicant
UNITED SURGICAL CORP.
15500-A ROCKFIELD BLVD.
IRVINE,  CA  92718
Applicant Contact TERRY F HERBECK
Correspondent
UNITED SURGICAL CORP.
15500-A ROCKFIELD BLVD.
IRVINE,  CA  92718
Correspondent Contact TERRY F HERBECK
Regulation Number886.4170
Classification Product Code
HPS  
Date Received01/20/1987
Decision Date 02/20/1987
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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