FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

UNICATCH

K Number: K770387 · Decision Apr 5, 1977
Classifications
1
FEI Numbers
294
Registration Numbers
294
Same Product Code
22
Applicant Total
7
Review Days
36

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Basic Information

Device Name
UNICATCH
K Number
K770387
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
864.3250
Medical Specialty
Pathology
Decision
Substantially Equivalent
Applicant
W.G. Whitney Corp.
Date Received
February 28, 1977
Decision Date
April 5, 1977
Product Code
FMH
Advisory Committee
Pathology
Review Advisory Committee
HO
Third Party
N

Classifications

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

Product Code Device Name
FMH Container, Specimen, Sterile

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K803299 COLD/HOT PACK
K800907 TOMAC WET DRESSING WARMER
K781322 STERILE WET DRESSING PACK