The following data is part of a premarket notification filed by Micrins, Ltd. with the FDA for Korber Arteriotomy Scissors.
Device ID | K884373 |
510k Number | K884373 |
Device Name: | KORBER ARTERIOTOMY SCISSORS |
Classification | Scissors, General, Surgical |
Applicant | MICRINS, LTD. 3174 DOOLITTLE DR. Northbrook, IL 60062 |
Contact | Bernhard Teitz |
Correspondent | Bernhard Teitz MICRINS, LTD. 3174 DOOLITTLE DR. Northbrook, IL 60062 |
Product Code | LRW |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-18 |
Decision Date | 1988-11-08 |