The following data is part of a premarket notification filed by Asap Endoscopic Products Gmbh with the FDA for Asap Arthroscope Models; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,.
Device ID | K031972 |
510k Number | K031972 |
Device Name: | ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00, |
Classification | Arthroscope |
Applicant | ASAP ENDOSCOPIC PRODUCTS GMBH KATHARINENSTR. 5 Luebeck, DE 23554 |
Contact | Martina Gunderoth |
Correspondent | Martina Gunderoth ASAP ENDOSCOPIC PRODUCTS GMBH KATHARINENSTR. 5 Luebeck, DE 23554 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-06-26 |
Decision Date | 2003-09-15 |
Summary: | summary |