510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K837106Substantially Equivalent

Elder Psoralite Series 2000 Uva Irradiation System

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

K837106 is the FDA 510(k) clearance record for ELDER PSORALITE SERIES 2000 UVA IRRADIATION SYSTEM, 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 K837106.

Clearance record

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