Atlas FDA

SURGI-SCRAPE

FDA 510(k) clearance K820443 · decided 1982-03-08

Clearance details

K-number
K820443
Device name
SURGI-SCRAPE
Applicant
Consolidated Medical Equipment, Inc.
Decision
Substantially Equivalent
Date received
1982-02-18
Decision date
1982-03-08
Days to decision
18 days
Clearance type
Traditional
Advisory committee
Unknown
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.