The following data is part of a premarket notification filed by Mtp Medical Technical Promotion Gmbh with the FDA for Mtp Laparomat Disposable Tubing Set.
| Device ID | K011360 |
| 510k Number | K011360 |
| Device Name: | MTP LAPAROMAT DISPOSABLE TUBING SET |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MTP MEDICAL TECHNICAL PROMOTION GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Contact | James A Lee |
| Correspondent | James A Lee 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 | 2001-05-03 |
| Decision Date | 2001-07-19 |