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

TECNOL SURGEON'S CAP

K Number: K873830 · Decision Oct 23, 1987
Classifications
1
FEI Numbers
312
Registration Numbers
312
Same Product Code
31
Applicant Total
35
Review Days
32

Basic Information

Device Name
TECNOL SURGEON'S CAP
K Number
K873830
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4040
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
TECNOL NEW JERSEY WOUND CARE, INC.
Date Received
September 21, 1987
Decision Date
October 23, 1987
Product Code
FYF
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
FYF Cap, Surgical

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K Number Device Name
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K911891 FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK
K911907 FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS
K896193 TECNOL LAZER(TM) SURGICAL MASK
K894205 TECNOL SILK STRIP
K893702 TECNOL GAITERS PRODUCT NUMBER 47725-010
K891187 TECNOL NASO-GASTRIC TUBE HOLDER
K891178 TECNOL SECURE-ALL TUBE HOLDER
K884440 TECNOL VARIABLE TENSION BANDAGE
K882640 TECNOL SECURE-ALL PELVIC TRACTION BELT
Search all 35 clearances from TECNOL NEW JERSEY WOUND CARE, INC. →