510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K852152Substantially Equivalent

Flexistand Major

Zygotek Assoc., London W12 8nz, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852152 is the FDA 510(k) clearance record for FLEXISTAND MAJOR, cleared for Zygotek Assoc. on . FDA records list one 510(k) clearance for Zygotek Assoc. As of , FDA records show no recalls naming K852152.

Clearance record

Decision date
Received
(172 days to decision)
Review panel
Unknown
Applicant
Zygotek Assoc. 17 Devonport Rd., London W12 8nz, GB
Third party review
No