The following data is part of a premarket notification filed by Mectra Labs, Inc. with the FDA for Suction Cautery Probe.
| Device ID | K955352 |
| 510k Number | K955352 |
| Device Name: | SUCTION CAUTERY PROBE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MECTRA LABS, INC. HIGHWAY 231 SOUTH R.R. #2, BOX 366 Bloomfield, IN 47424 |
| Contact | Charles E Allgood |
| Correspondent | Charles E Allgood MECTRA LABS, INC. HIGHWAY 231 SOUTH R.R. #2, BOX 366 Bloomfield, IN 47424 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-21 |
| Decision Date | 1996-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817984010881 | K955352 | 000 |
| 10817984010553 | K955352 | 000 |
| 10817984010546 | K955352 | 000 |
| 10817984010539 | K955352 | 000 |
| 10817984010522 | K955352 | 000 |
| 10817984010515 | K955352 | 000 |
| 10817984010508 | K955352 | 000 |
| 10817984010492 | K955352 | 000 |
| 10817984010485 | K955352 | 000 |
| 10817984010478 | K955352 | 000 |
| 10817984010461 | K955352 | 000 |
| 10817984010454 | K955352 | 000 |
| 10817984010447 | K955352 | 000 |
| 10817984010430 | K955352 | 000 |
| 10817984010423 | K955352 | 000 |
| 10817984010416 | K955352 | 000 |
| 10817984010560 | K955352 | 000 |
| 10817984010577 | K955352 | 000 |
| 10817984010874 | K955352 | 000 |
| 10817984010867 | K955352 | 000 |
| 10817984010850 | K955352 | 000 |
| 10817984010843 | K955352 | 000 |
| 10817984010836 | K955352 | 000 |
| 10817984010829 | K955352 | 000 |
| 10817984010812 | K955352 | 000 |
| 10817984010805 | K955352 | 000 |
| 10817984010799 | K955352 | 000 |
| 10817984010782 | K955352 | 000 |
| 10817984010775 | K955352 | 000 |
| 10817984010768 | K955352 | 000 |
| 10817984010607 | K955352 | 000 |
| 10817984010591 | K955352 | 000 |
| 10817984010584 | K955352 | 000 |
| 10817984010409 | K955352 | 000 |