Atlas FDA

COMPASEP

FDA 510(k) clearance K920649 · decided 1992-07-23

Clearance details

K-number
K920649
Device name
COMPASEP
Applicant
Wilde-USA, Inc.
Decision
Substantially Equivalent
Date received
1992-02-12
Decision date
1992-07-23
Days to decision
162 days
Clearance type
Traditional
Product code
FMC
Device class
1
Regulation number
880.6250
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Chicago, IL, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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LATEX GLOVE APPLICATION AND REMOVAL SYSTEM (K905127)Success Builders Intl., Inc.1991-01-30
PATIENT EXAMINATION GLOVE/HYPOALLERGENIC (K905109)Tactyl Technologies, Inc.1990-11-21
COMFIT, PATIENT EXAMINATION GLOVES (K903746)Wembley Rubber Products (M) Sdn Bhd1990-09-05
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Recalls involving this device

No recalls on record reference this clearance.