510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801175Substantially Equivalent

Silastic II Mammary Implant

Dow Corning Corp. Healthcare Industries Materials, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801175 is the FDA 510(k) clearance record for SILASTIC II MAMMARY IMPLANT, cleared for Dow Corning Corp. Healthcare Industries Materials on . FDA records list 31 510(k) clearances for Dow Corning Corp. Healthcare Industries Materials, from to . As of , FDA records show no recalls naming K801175.

Clearance record

Decision date
Received
(216 days to decision)
Review panel
Unknown
Applicant
Dow Corning Corp. Healthcare Industries Materials 803 N. Front St. Suite 3, Mchenry IL
Third party review
No