The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbeflo Clevercap Hybrid Tubing/cap Sets For Olympus Models 160 And 180 Series Scopes.
| Device ID | K103696 |
| 510k Number | K103696 |
| Device Name: | ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES |
| Classification | Pump, Air, Non-manual, For Endoscope |
| 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 | FEQ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-17 |
| Decision Date | 2011-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147015678 | K103696 | 000 |
| 04050147013575 | K103696 | 000 |
| 04050147013551 | K103696 | 000 |
| 04050147013193 | K103696 | 000 |
| 04050147013179 | K103696 | 000 |
| 04050147013155 | K103696 | 000 |
| 04050147022645 | K103696 | 000 |