Atlas FDA

SOFT-COVER

FDA 510(k) clearance K921928 · decided 1992-11-06

Clearance details

K-number
K921928
Device name
SOFT-COVER
Applicant
Adroit Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
1992-04-24
Decision date
1992-11-06
Days to decision
196 days
Clearance type
Traditional
Product code
FMW
Device class
1
Regulation number
880.6190
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Morganton, NC, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.