The following data is part of a premarket notification filed by Mtp Medical Technical Promotion Gmbh with the FDA for Mtp Hamou Endomat Disposable Tubing Sets.
Device ID | K990910 |
510k Number | K990910 |
Device Name: | MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS |
Classification | Hysteroscope (and Accessories) |
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 | HIH |
CFR Regulation Number | 884.1690 [🔎] |
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 |
---|---|---|
04048438001103 | K990910 | 000 |