The following data is part of a premarket notification filed by I.c. Medical, Inc. with the FDA for Telescoping Penevac.
| Device ID | K954088 |
| 510k Number | K954088 |
| Device Name: | TELESCOPING PENEVAC |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | I.C. MEDICAL, INC. 5170 PHELPS RD. SUITE D Glendale, AZ 85306 |
| Contact | Kurt Hasper |
| Correspondent | Kurt Hasper I.C. MEDICAL, INC. 5170 PHELPS RD. SUITE D Glendale, AZ 85306 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-31 |
| Decision Date | 1995-09-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817688020004 | K954088 | 000 |
| 00817688020257 | K954088 | 000 |
| 00817688020271 | K954088 | 000 |
| 00817688020295 | K954088 | 000 |
| 00817688020318 | K954088 | 000 |
| 00817688020332 | K954088 | 000 |
| 00817688020356 | K954088 | 000 |
| 00817688020370 | K954088 | 000 |
| 00817688020394 | K954088 | 000 |
| 00817688020233 | K954088 | 000 |
| 00817688020219 | K954088 | 000 |
| 00817688020196 | K954088 | 000 |
| 00817688020028 | K954088 | 000 |
| 00817688020059 | K954088 | 000 |
| 00817688020073 | K954088 | 000 |
| 00817688020097 | K954088 | 000 |
| 00817688020110 | K954088 | 000 |
| 00817688020134 | K954088 | 000 |
| 00817688020158 | K954088 | 000 |
| 00817688020172 | K954088 | 000 |
| 00817688020431 | K954088 | 000 |
| 00817688020455 | K954088 | 000 |
| 00817688022015 | K954088 | 000 |
| 00817688022039 | K954088 | 000 |
| 00817688022046 | K954088 | 000 |
| 00817688022053 | K954088 | 000 |
| 00817688022152 | K954088 | 000 |
| 00817688022176 | K954088 | 000 |
| 00817688022237 | K954088 | 000 |
| 00817688022251 | K954088 | 000 |
| 00817688021926 | K954088 | 000 |
| 00817688021919 | K954088 | 000 |
| 00817688021049 | K954088 | 000 |
| 00817688020479 | K954088 | 000 |
| 00817688020905 | K954088 | 000 |
| 00817688020929 | K954088 | 000 |
| 00817688020943 | K954088 | 000 |
| 00817688020967 | K954088 | 000 |
| 00817688020981 | K954088 | 000 |
| 00817688021001 | K954088 | 000 |
| 00817688021025 | K954088 | 000 |
| 00817688022459 | K954088 | 000 |