The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Ellipti-punch.
| Device ID | K854159 |
| 510k Number | K854159 |
| Device Name: | ELLIPTI-PUNCH |
| Classification | Apparatus, Air Handling, Enclosure |
| Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Contact | Rebecca G Walker |
| Correspondent | Rebecca G Walker ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Product Code | FZI |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-11 |
| Decision Date | 1985-11-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ELLIPTI-PUNCH 73555543 1392255 Dead/Cancelled |
DERMATOLGOICAL PRODUCTS OF TEXAS, INC. 1985-08-26 |