The following data is part of a premarket notification filed by Mtp Medical Technical Promotion Gmbh with the FDA for Mtp Extraction Bag.
| Device ID | K990912 |
| 510k Number | K990912 |
| Device Name: | MTP EXTRACTION BAG |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MTP MEDICAL TECHNICAL PROMOTION GMBH P.O. BOX 1954 Culver City, CA 90232 |
| Contact | Kevin Kennan |
| Correspondent | Kevin Kennan MTP MEDICAL TECHNICAL PROMOTION GMBH P.O. BOX 1954 Culver City, CA 90232 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-18 |
| Decision Date | 1999-06-09 |
| Summary: | summary |