FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

UNITED SURGICAL CORP. CRYOPTIC PLUS

K Number: K870195 · Decision Feb 20, 1987
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
10
Applicant Total
7
Review Days
31

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Basic Information

Device Name
UNITED SURGICAL CORP. CRYOPTIC PLUS
K Number
K870195
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
886.4170
Medical Specialty
Ophthalmic
Decision
Substantially Equivalent
Applicant
United Surgical Corp.
Date Received
January 20, 1987
Decision Date
February 20, 1987
Product Code
HPS
Advisory Committee
Ophthalmic
Review Advisory Committee
OP
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
HPS Unit, Cryophthalmic

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K870194 UNITED SURGICAL CORP. DIATHERMIC PLUS
K860014 SYSTEMS PLUS
K830741 PARAMETRIC STERILITY RELEASE OF AUTO