The following data is part of a premarket notification filed by Mtp Medical Technical Promotion Gmbh with the FDA for Mtp Arthropump Disposable Tubing Set.
Device ID | K990911 |
510k Number | K990911 |
Device Name: | MTP ARTHROPUMP DISPOSABLE TUBING SET |
Classification | Arthroscope |
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 | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-18 |
Decision Date | 1999-06-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04048438003176 | K990911 | 000 |
04048438002964 | K990911 | 000 |
04048438002940 | K990911 | 000 |
04048438000922 | K990911 | 000 |