Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K827376Substantially Equivalent

Biopsy Guide Attachment for Use with Fetascan 800

Cranbury Medical Labs, Inc., Mchenry IL / Traditional, Substantially Equivalent

K827376 is the FDA 510(k) clearance record for BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 800, cleared for Cranbury Medical Labs, Inc. on . FDA records list 7 510(k) clearances for Cranbury Medical Labs, Inc., from to . As of , FDA records show no recalls naming K827376.

Clearance record

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