The following data is part of a premarket notification filed by Baitella Ag with the FDA for Fisso Holding System.
Device ID | K070509 |
510k Number | K070509 |
Device Name: | FISSO HOLDING SYSTEM |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | BAITELLA AG AMSTEL 320-I Amsterdam, NL 1017ap |
Contact | Angelika Scherp |
Correspondent | Angelika Scherp BAITELLA AG AMSTEL 320-I Amsterdam, NL 1017ap |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-02-22 |
Decision Date | 2007-03-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M274620WHS8001 | K070509 | 000 |