The following data is part of a premarket notification filed by Mtp Medical Technical Promotion Gmbh with the FDA for Mtp Disposable Equipment Covers, Karl Storz 15 Touch Screen.
Device ID | K091178 |
510k Number | K091178 |
Device Name: | MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN |
Classification | Cover, Barrier, Protective |
Applicant | MTP MEDICAL TECHNICAL PROMOTION GMBH 2151 E. GRAND AVENUE El Segundo, CA 90245 -5017 |
Contact | Yvonne Fernandez |
Correspondent | Yvonne Fernandez MTP MEDICAL TECHNICAL PROMOTION GMBH 2151 E. GRAND AVENUE El Segundo, CA 90245 -5017 |
Product Code | MMP |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-04-22 |
Decision Date | 2009-07-31 |