The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbe Apc Raspatory Handle And Tip, Model 20132-102, 20132-103.
| Device ID | K992764 |
| 510k Number | K992764 |
| Device Name: | ERBE APC RASPATORY HANDLE AND TIP, MODEL 20132-102, 20132-103 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ERBE USA, INC. 2225 NORTHWEST PKWY. Marietta, GA 30067 |
| Contact | Scott Cundy |
| Correspondent | Scott Cundy ERBE USA, INC. 2225 NORTHWEST PKWY. Marietta, GA 30067 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-17 |
| Decision Date | 1999-10-14 |
| Summary: | summary |