510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810656Substantially Equivalent

Sr-Ivoseal(soft Relining)

J. Aderer, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810656 is the FDA 510(k) clearance record for SR-IVOSEAL(SOFT RELINING), cleared for J. Aderer, Inc. on . FDA records list 24 510(k) clearances for J. Aderer, Inc., from to . As of , FDA records show no recalls naming K810656.

Clearance record

Decision date
Received
(47 days to decision)
Review panel
Unknown
Applicant
J. Aderer, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No