510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840456Substantially Equivalent

Sun-Lite 1

Suncoast Medical Manufacturers, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840456 is the FDA 510(k) clearance record for SUN-LITE 1, cleared for Suncoast Medical Manufacturers, Inc. on . FDA records list 31 510(k) clearances for Suncoast Medical Manufacturers, Inc., from to . As of , FDA records show no recalls naming K840456.

Clearance record

Decision date
Received
(71 days to decision)
Review panel
Unknown
Applicant
Suncoast Medical Manufacturers, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No