The following data is part of a premarket notification filed by Hobbs Medical, Inc. with the FDA for Touchsoft Coagulator With Banana Fitting, Model 4581 And With Universal Fitting, Model 4581-u.
| Device ID | K093079 |
| 510k Number | K093079 |
| Device Name: | TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | HOBBS MEDICAL, INC. 8 SPRING ST. Stafford Springs, CT 06076 |
| Contact | Emily Madsen |
| Correspondent | Emily Madsen HOBBS MEDICAL, INC. 8 SPRING ST. Stafford Springs, CT 06076 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-30 |
| Decision Date | 2010-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M849G11200400 | K093079 | 000 |