The following data is part of a premarket notification filed by Talboy, Inc. with the FDA for Tal-clip.
Device ID | K843816 |
510k Number | K843816 |
Device Name: | TAL-CLIP |
Classification | Clamp, Surgical, General & Plastic Surgery |
Applicant | TALBOY, INC. P.O. BOX 2831 Boise , ID 83701 - |
Contact | Glenn E Talboy |
Correspondent | Glenn E Talboy TALBOY, INC. P.O. BOX 2831 Boise , ID 83701 - |
Product Code | GDJ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-28 |
Decision Date | 1984-10-31 |