The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbeflo 2 Disposable Tubing System.
| Device ID | K103235 |
| 510k Number | K103235 |
| Device Name: | ERBEFLO 2 DISPOSABLE TUBING SYSTEM |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | ERBE USA, INC. 2225 NORTHWEST PKWY. Marietta, GA 30067 |
| Contact | John Tartal |
| Correspondent | John Tartal ERBE USA, INC. 2225 NORTHWEST PKWY. Marietta, GA 30067 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-02 |
| Decision Date | 2010-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147021303 | K103235 | 000 |
| 04050147013322 | K103235 | 000 |
| 04050147013346 | K103235 | 000 |
| 04050147013377 | K103235 | 000 |
| 04050147013391 | K103235 | 000 |
| 04050147013445 | K103235 | 000 |
| 04050147013469 | K103235 | 000 |
| 04050147013483 | K103235 | 000 |
| 04050147013667 | K103235 | 000 |
| 04050147013674 | K103235 | 000 |
| 04050147013704 | K103235 | 000 |
| 04050147013292 | K103235 | 000 |