Atlas FDA

STAPLE REMOVER

FDA 510(k) clearance K853286 · decided 1985-08-21

Clearance details

K-number
K853286
Device name
STAPLE REMOVER
Applicant
I M, Inc.
Decision
Substantially Equivalent
Date received
1985-08-05
Decision date
1985-08-21
Days to decision
16 days
Clearance type
Traditional
Advisory committee
Unknown
Location
Fairfield, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.