The following data is part of a premarket notification filed by Mtp Medical Technical Promotion Gmbh with the FDA for Mtp Disposable Trocars.
Device ID | K994066 |
510k Number | K994066 |
Device Name: | MTP DISPOSABLE TROCARS |
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 | 1999-12-01 |
Decision Date | 2000-01-20 |
Summary: | summary |