The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Radovan Tissue Expander (option Integral Inject.).
Device ID | K884250 |
510k Number | K884250 |
Device Name: | RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.) |
Classification | Expander, Skin, Inflatable |
Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
Contact | Byron Wickett |
Correspondent | Byron Wickett 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 | 1988-10-11 |
Decision Date | 1989-06-12 |