The following data is part of a premarket notification filed by Mtp Medical Technical Promotion Gmbh with the FDA for Mtp Disposable Trocar Valves.
| Device ID | K000337 |
| 510k Number | K000337 |
| Device Name: | MTP DISPOSABLE TROCAR VALVES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MTP MEDICAL TECHNICAL PROMOTION GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Contact | Kevin Kennan |
| Correspondent | Kevin Kennan MTP MEDICAL TECHNICAL PROMOTION GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-03 |
| Decision Date | 2000-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048438000366 | K000337 | 000 |