The following data is part of a premarket notification filed by Luther Medical Products, Inc. with the FDA for Blunt T-peel Introducer Model Number Pe-16picb, Pe-18picb, Pe-20picb, Pe-24picb.
| Device ID | K982797 |
| 510k Number | K982797 |
| Device Name: | BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB |
| Classification | Introducer, Catheter |
| Applicant | LUTHER MEDICAL PRODUCTS, INC. 14332 CHAMBERS RD. Tustin, CA 92780 -6912 |
| Contact | Kathleen Roberts |
| Correspondent | Kathleen Roberts LUTHER MEDICAL PRODUCTS, INC. 14332 CHAMBERS RD. Tustin, CA 92780 -6912 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-10 |
| Decision Date | 1998-11-30 |
| Summary: | summary |