The following data is part of a premarket notification filed by King & Spalding with the FDA for Hemo-o-lok.
Device ID | K941972 |
510k Number | K941972 |
Device Name: | HEMO-O-LOK |
Classification | Clip, Implantable |
Applicant | KING & SPALDING 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 -4706 |
Contact | Edward Basile |
Correspondent | Edward Basile KING & SPALDING 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 -4706 |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-22 |
Decision Date | 1994-06-29 |