The following data is part of a premarket notification filed by North American Medical, Inc. with the FDA for Ddv Ligator.
Device ID | K921304 |
510k Number | K921304 |
Device Name: | DDV LIGATOR |
Classification | Surgical Instruments, G-u, Manual (and Accessories) |
Applicant | NORTH AMERICAN MEDICAL, INC. 5220 75TH ST. SUITE 3 Lubbock, TX 79424 |
Contact | Lisa Jones |
Correspondent | Lisa Jones NORTH AMERICAN MEDICAL, INC. 5220 75TH ST. SUITE 3 Lubbock, TX 79424 |
Product Code | KOA |
CFR Regulation Number | 876.4730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-11 |
Decision Date | 1992-10-05 |