The following data is part of a premarket notification filed by Mcghan Medical Corp. with the FDA for Mcghan Tissue Expander Fill Kit.
| Device ID | K853014 |
| 510k Number | K853014 |
| Device Name: | MCGHAN TISSUE EXPANDER FILL KIT |
| Classification | Expander, Skin, Inflatable |
| Applicant | MCGHAN MEDICAL CORP. 700 WARD DR. Santa Barbara, CA 93111 |
| Contact | Laurens Licnty |
| Correspondent | Laurens Licnty 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 | 1985-07-17 |
| Decision Date | 1985-09-18 |