The following data is part of a premarket notification filed by Dacomed Corp. with the FDA for Forder Retractor.
Device ID | K811693 |
510k Number | K811693 |
Device Name: | FORDER RETRACTOR |
Classification | Surgical Instruments, G-u, Manual (and Accessories) |
Applicant | DACOMED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KOA |
CFR Regulation Number | 876.4730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-06-15 |
Decision Date | 1981-06-26 |