The following data is part of a premarket notification filed by Asap Endoscopic Products Gmbh with the FDA for Asap Muitiscope.
Device ID | K121261 |
510k Number | K121261 |
Device Name: | ASAP MUITISCOPE |
Classification | Arthroscope |
Applicant | ASAP ENDOSCOPIC PRODUCTS GMBH AMSTEL 320-I Amsterdam, NL 1017ap |
Contact | Angelika Scherp |
Correspondent | Angelika Scherp ASAP ENDOSCOPIC PRODUCTS GMBH AMSTEL 320-I Amsterdam, NL 1017ap |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-04-26 |
Decision Date | 2013-01-08 |
Summary: | summary |