The following data is part of a premarket notification filed by Egon Faulhaber Surgical Instruments Pinzetten with the FDA for Non Stick Bipolar Forceps Model 07/xxx, Bipolar Forceps Model 08/xxx, Monopolar Forceps Model 09/xxx.
| Device ID | K101080 |
| 510k Number | K101080 |
| Device Name: | NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | EGON FAULHABER SURGICAL INSTRUMENTS PINZETTEN UNTERER WINKEL 3 Wurmlingen, DE D-78573 |
| Contact | Harald Jung |
| Correspondent | Harald Jung EGON FAULHABER SURGICAL INSTRUMENTS PINZETTEN UNTERER WINKEL 3 Wurmlingen, DE D-78573 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-19 |
| Decision Date | 2010-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B09927009510 | K101080 | 000 |
| B0992700842NS0 | K101080 | 000 |
| B0992700840NS0 | K101080 | 000 |
| B0992700839NS0 | K101080 | 000 |
| B0992700835NS0 | K101080 | 000 |
| B09927008140 | K101080 | 000 |
| B09927008120 | K101080 | 000 |
| B0992700802NS0 | K101080 | 000 |
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| B0992700560NS0 | K101080 | 000 |
| B0992700558NS0 | K101080 | 000 |
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| 04250676735348 | K101080 | 000 |
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