The following data is part of a premarket notification filed by Mtp Medical Technical Promotion Gmbh with the FDA for Mtp Uropump Disposable Tubing Set.
Device ID | K990909 |
510k Number | K990909 |
Device Name: | MTP UROPUMP DISPOSABLE TUBING SET |
Classification | System, Irrigation, Urological |
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 | LJH |
CFR Regulation Number | 876.5130 [🔎] |
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 |