K827375Substantially Equivalent

Biopsy Guide Attachment for Use with Fetascan 2000 and 2000A

Name: K827375 Biopsy Guide Attachment for Use with Fetascan 2000 and 2000A
Creator: Cranbury Medical Labs, Inc.
Published: 1982-07-02
License: https://open.fda.gov/license/

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

FDA source

K827375 is the FDA 510(k) clearance record for BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 2000 AND 2000A, cleared for Cranbury Medical Labs, Inc. on 1982-07-02. FDA records list 7 510(k) clearances for Cranbury Medical Labs, Inc., from 1982-01-28 to 1982-12-14. As of 2026-09-10, FDA records show no recalls naming K827375.

Clearance record

Decision date: 1982-07-02
Received: 1982-04-13 (80 days to decision)
Review panel: Unknown
Applicant: Cranbury Medical Labs, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No