The following data is part of a premarket notification filed by Medovations, Inc. with the FDA for Trocar Catheter.
| Device ID | K913678 |
| 510k Number | K913678 |
| Device Name: | TROCAR CATHETER |
| Classification | Bag, Intestine |
| Applicant | MEDOVATIONS, INC. 102 EAST KEEFE AVE. Milwaukee, WI 53212 |
| Contact | Brian E Larson |
| Correspondent | Brian E Larson MEDOVATIONS, INC. 102 EAST KEEFE AVE. Milwaukee, WI 53212 |
| Product Code | KGY |
| CFR Regulation Number | 878.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-19 |
| Decision Date | 1991-12-16 |