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

COTTON ROLLS

K Number: K802429 · Decision Oct 23, 1980
Classifications
1
FEI Numbers
206
Registration Numbers
206
Same Product Code
13
Applicant Total
4
Review Days
20

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Basic Information

Device Name
COTTON ROLLS
K Number
K802429
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.6050
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Worldwide Surgical Gauze
Date Received
October 3, 1980
Decision Date
October 23, 1980
Product Code
EFN
Advisory Committee
Dental
Review Advisory Committee
DE
Third Party
N

Classifications

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

Product Code Device Name
EFN Cotton, Roll

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Other Clearances by Worldwide Surgical Gauze

K Number Device Name
K823455 SURGICAL GAUZE
K812572 GAUZE SPONGES
K803172 GAUZE SPONGES