510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861937Substantially Equivalent

Aquacel Surgical Prep Pads

Advanced Ortho-Technology, Inc., Tuckahoe NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861937 is the FDA 510(k) clearance record for AQUACEL SURGICAL PREP PADS, cleared for Advanced Ortho-Technology, Inc. on . FDA records list 3 510(k) clearances for Advanced Ortho-Technology, Inc., from to . As of , FDA records show no recalls naming K861937.

Clearance record

Decision date
Received
(17 days to decision)
Review panel
Unknown
Applicant
Advanced Ortho-Technology, Inc. 150 Marbledale Rd., Tuckahoe NY
Third party review
No