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
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K813094Substantially Equivalent

Acetabular Cement Compressor

Richard'S Medical Equip., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813094 is the FDA 510(k) clearance record for ACETABULAR CEMENT COMPRESSOR, cleared for Richard'S Medical Equip., Inc. on . FDA records list 48 510(k) clearances for Richard'S Medical Equip., Inc., from to . As of , FDA records show no recalls naming K813094.

Clearance record

Decision date
Received
(17 days to decision)
Review panel
Unknown
Applicant
Richard'S Medical Equip., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No