The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbotom Icc Bipolar.
| Device ID | K953159 |
| 510k Number | K953159 |
| Device Name: | ERBOTOM ICC BIPOLAR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ERBE USA, INC. 1070 THORNWOOD LN. Dacula, GA 30211 |
| Contact | Michael A Clark |
| Correspondent | Michael A Clark ERBE USA, INC. 1070 THORNWOOD LN. Dacula, GA 30211 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-08 |
| Decision Date | 1995-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147002555 | K953159 | 000 |
| 04050147002548 | K953159 | 000 |