The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valley Model E2750-t Pencil Grip Laparoscopic.
Device ID | K941968 |
510k Number | K941968 |
Device Name: | VALLEY MODEL E2750-T PENCIL GRIP LAPAROSCOPIC |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
Contact | Charles M Copperberg |
Correspondent | Charles M Copperberg VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-22 |
Decision Date | 1994-05-10 |