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

BEDPAN, SINGLE PATIENT USE, TECNOL

K Number: K760307 · Decision Aug 11, 1976
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
4
Applicant Total
35
Review Days
16

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Basic Information

Device Name
BEDPAN, SINGLE PATIENT USE, TECNOL
K Number
K760307
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
880.6730
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Tecnol New Jersey Wound Care, Inc.
Date Received
July 26, 1976
Decision Date
August 11, 1976
Product Code
FOB
Advisory Committee
General Hospital
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
FOB Bedpan

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Other Clearances by Tecnol New Jersey Wound Care, Inc.

K Number Device Name
K913043 MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS
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. →