The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Rapid-span (tm) Tissue Expander.
Device ID | K883303 |
510k Number | K883303 |
Device Name: | MENTOR RAPID-SPAN (TM) TISSUE EXPANDER |
Classification | Expander, Skin, Inflatable |
Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
Contact | Byron Wicket |
Correspondent | Byron Wicket MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
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 | 1988-08-04 |
Decision Date | 1988-08-26 |