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

SWR DISPOSABLE PREP RAZOR

K Number: K810112 · Decision Feb 4, 1981
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
66
Applicant Total
56
Review Days
19

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Basic Information

Device Name
SWR DISPOSABLE PREP RAZOR
K Number
K810112
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4800
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
G.D. Searle and Co.
Date Received
January 16, 1981
Decision Date
February 4, 1981
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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Other Clearances by G.D. Searle and Co.

K Number Device Name
K821159 IN-LINE OXYGEN MONITORING SYSTEM
K811068 BYPASS COIL
K811071 VENOUS OXYGEN PROBE
K803238 INTRAVASCULAR CATHETER
K810630 SILICONE ELASTOMER COATED LATEX FOLEY
K810131 ADMINISTRATION SET
K802485 SEARLE VASCULAR LOOPS
K801805 METRONIDAZOLE DISCS
K802213 WHITE KNIGHT BOVIE CORD/SUCTION TUBE
K802280 WHITE KNIGHT DRAPE SEAL
Search all 56 clearances from G.D. Searle and Co. →