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 |