510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K850502Substantially Equivalent

H/g Cup Positioner (1520) Left-500Pcs Right 500Pcs

The Huxley Instrument Corp., Penn Yan NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850502 is the FDA 510(k) clearance record for H/G CUP POSITIONER (1520) LEFT-500PCS RIGHT 500PCS, cleared for The Huxley Instrument Corp. on . FDA records list 53 510(k) clearances for The Huxley Instrument Corp., from to . As of , FDA records show no recalls naming K850502.

Clearance record

Decision date
Received
(21 days to decision)
Review panel
Unknown
Applicant
The Huxley Instrument Corp. 215 Main St., Penn Yan NY
Third party review
No