The following data is part of a premarket notification filed by Innervision, Inc. with the FDA for Innervision,inc. Laparoscopic Electrodes.
Device ID | K940750 |
510k Number | K940750 |
Device Name: | INNERVISION,INC. LAPAROSCOPIC ELECTRODES |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | INNERVISION, INC. 1755 LYNNFIELD RD. SUITE 190 Memphis, TN 38119 |
Contact | Frank M Lewis |
Correspondent | Frank M Lewis INNERVISION, INC. 1755 LYNNFIELD RD. SUITE 190 Memphis, TN 38119 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-18 |
Decision Date | 1994-08-23 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00853508002140 | K940750 | 000 |
00853508002072 | K940750 | 000 |