K842748Substantially Equivalent

Surgitek Reconstruc-Nipple Prosthesis

Name: K842748 Surgitek Reconstruc-Nipple Prosthesis
Creator: Medical Engineering Corp.
Published: 1984-09-26
License: https://open.fda.gov/license/

Medical Engineering Corp., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K842748 is the FDA 510(k) clearance record for SURGITEK RECONSTRUC-NIPPLE PROSTHESIS, cleared for Medical Engineering Corp. on 1984-09-26. FDA records list 28 510(k) clearances for Medical Engineering Corp., from 1977-02-01 to 1993-11-18. As of 2026-09-10, FDA records show no recalls naming K842748.

Clearance record

Decision date: 1984-09-26
Received: 1984-07-13 (75 days to decision)
Review panel: Unknown
Applicant: Medical Engineering Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No