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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K837109Substantially Equivalent

Unknown

Elder Pharmaceuticals, Inc., Bryan OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K837109 is the FDA 510(k) clearance record for UNKNOWN, cleared for Elder Pharmaceuticals, Inc. on . FDA records list 4 510(k) clearances for Elder Pharmaceuticals, Inc., from to . As of , FDA records show no recalls naming K837109.

Clearance record

Decision date
Received
(68 days to decision)
Review panel
Unknown
Applicant
Elder Pharmaceuticals, Inc. 705 E. Mulberry St., Bryan OH
Third party review
No