The following data is part of a premarket notification filed by Mcghan Medical Corp. with the FDA for Mcghan Magna-site(tm) Tissue Expander.
Device ID | K862203 |
510k Number | K862203 |
Device Name: | MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER |
Classification | Expander, Skin, Inflatable |
Applicant | MCGHAN MEDICAL CORP. 700 WARD DR. Santa Barbara, CA 93111 |
Contact | Laurens Lichty |
Correspondent | Laurens Lichty MCGHAN MEDICAL CORP. 700 WARD DR. Santa Barbara, CA 93111 |
Product Code | LCJ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-10 |
Decision Date | 1986-07-23 |