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 |