510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K820443Substantially Equivalent

Surgi-Scrape

Consolidated Medical Equipment Company, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820443 is the FDA 510(k) clearance record for SURGI-SCRAPE, cleared for Consolidated Medical Equipment, Inc. on . FDA records list 15 510(k) clearances for Consolidated Medical Equipment, Inc., from to . As of , FDA records show no recalls naming K820443.

Clearance record

Decision date
Received
(18 days to decision)
Review panel
Unknown
Applicant
Consolidated Medical Equipment, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No