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

KEY VASCULAR LOOPS

K Number: K896676 · Decision Feb 27, 1990
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
66
Applicant Total
6
Review Days
92

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Basic Information

Device Name
KEY VASCULAR LOOPS
K Number
K896676
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4800
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Key Surgical, Inc.
Date Received
November 27, 1989
Decision Date
February 27, 1990
Product Code
KDC
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

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

Product Code Device Name
KDC Instrument, Surgical, Disposable

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K Number Device Name
K150532 Universal Light Handle Cover, Light Handle Cover
K151222 Cautery Tip Cleaner
K910328 KEY COMFORT GRIPS
K896472 KEY VASCULAR BOOTIES
K895591 SILICONE INSTRUMENT SHODS