FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

STERILE ABSORBENT GAUZE BURN & SOUND

K Number: K840745 · Decision Apr 23, 1984
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
33
Review Days
61

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Basic Information

Device Name
STERILE ABSORBENT GAUZE BURN & SOUND
K Number
K840745
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Applicant
Chesebrough-Pond'S U.S.A. Co.
Date Received
February 22, 1984
Decision Date
April 23, 1984
Product Code
FRO
Advisory Committee
Unknown
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
FRO Dressing, Wound, Drug

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Other Clearances by Chesebrough-Pond'S U.S.A. Co.

K Number Device Name
K863866 RESPIRADYNE II(TM)
K862803 CHESEBROUGH POND'S HYDROCOLLOID DRESSING
K851383 BLISTERFILM TRANSPARENT DRESSING
K851382 CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING
K851539 CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO
K843567 KANGAROO NASOGASTRIC FEEDING TUBE
K844186 CONTINENT STOMA SYSTEM & ACCESSORIES
K845010 CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH
K844789 KANGAROO ACCESS II ENTERAL FEEDING CONTAINER
K843128 FEMALE URINARY INCONTINENCE SYS
Search all 33 clearances from Chesebrough-Pond'S U.S.A. Co. →