The following data is part of a premarket notification filed by Tri-stage, Inc. with the FDA for Tissue Punch.
| Device ID | K882834 |
| 510k Number | K882834 |
| Device Name: | TISSUE PUNCH |
| Classification | Burnisher, Operative |
| Applicant | TRI-STAGE, INC. 5897 OBERLIN DR. #205 San Diego, CA 92121 |
| Contact | Alan Donald |
| Correspondent | Alan Donald TRI-STAGE, INC. 5897 OBERLIN DR. #205 San Diego, CA 92121 |
| Product Code | EKJ |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-08 |
| Decision Date | 1988-08-02 |