510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812089Substantially Equivalent

Polaroid Radiographic Film Cassette

Polaroid Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812089 is the FDA 510(k) clearance record for POLAROID RADIOGRAPHIC FILM CASSETTE, cleared for Polaroid Corp. on . FDA records list 5 510(k) clearances for Polaroid Corp., from to . As of , FDA records show no recalls naming K812089.

Clearance record

Decision date
Received
(40 days to decision)
Review panel
Unknown
Applicant
Polaroid Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No