The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Contour Profile Tissue Expander.
Device ID | K011500 |
510k Number | K011500 |
Device Name: | MENTOR CONTOUR PROFILE TISSUE EXPANDER |
Classification | Expander, Skin, Inflatable |
Applicant | MENTOR CORP. 201 MENTOR DR. Santa Barbara, CA 93111 |
Contact | Donna Crawford |
Correspondent | Donna Crawford MENTOR CORP. 201 MENTOR 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 | 2001-05-16 |
Decision Date | 2001-12-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00081317004042 | K011500 | 000 |
00081317002352 | K011500 | 000 |
00081317002345 | K011500 | 000 |
00081317002338 | K011500 | 000 |
00081317002321 | K011500 | 000 |
00081317002314 | K011500 | 000 |
00081317002307 | K011500 | 000 |
00081317002291 | K011500 | 000 |
00081317002284 | K011500 | 000 |
00081317002277 | K011500 | 000 |
00081317002260 | K011500 | 000 |
00081317002253 | K011500 | 000 |
00081317002246 | K011500 | 000 |
00081317002239 | K011500 | 000 |
00081317002222 | K011500 | 000 |
00081317002215 | K011500 | 000 |
00081317002208 | K011500 | 000 |
00081317002192 | K011500 | 000 |
00081317002369 | K011500 | 000 |
00081317003618 | K011500 | 000 |
00081317003625 | K011500 | 000 |
00081317003793 | K011500 | 000 |
00081317003786 | K011500 | 000 |
00081317003779 | K011500 | 000 |
00081317003762 | K011500 | 000 |
00081317003755 | K011500 | 000 |
00081317003748 | K011500 | 000 |
00081317003731 | K011500 | 000 |
00081317003724 | K011500 | 000 |
00081317003717 | K011500 | 000 |
00081317003700 | K011500 | 000 |
00081317003694 | K011500 | 000 |
00081317003687 | K011500 | 000 |
00081317003670 | K011500 | 000 |
00081317003663 | K011500 | 000 |
00081317003656 | K011500 | 000 |
00081317003649 | K011500 | 000 |
00081317003632 | K011500 | 000 |
00081317002185 | K011500 | 000 |