The following data is part of a premarket notification filed by Kramer Const with the FDA for Ellipse Punch.
| Device ID | K904869 |
| 510k Number | K904869 |
| Device Name: | ELLIPSE PUNCH |
| Classification | Punch, Surgical |
| Applicant | KRAMER CONST 819 UNIVERSITY AVENURE Palo Alto, CA 94301 |
| Contact | Jesse Kramer |
| Correspondent | Jesse Kramer KRAMER CONST 819 UNIVERSITY AVENURE Palo Alto, CA 94301 |
| Product Code | LRY |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-29 |
| Decision Date | 1991-03-06 |