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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K823643Substantially Equivalent

Inflatable Pillow

Fred Sammons, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823643 is the FDA 510(k) clearance record for INFLATABLE PILLOW, cleared for Fred Sammons, Inc. on . FDA records list 278 510(k) clearances for Fred Sammons, Inc., from to . As of , FDA records show no recalls naming K823643.

Clearance record

Decision date
Received
(59 days to decision)
Review panel
Unknown
Applicant
Fred Sammons, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No