The following data is part of a premarket notification filed by Microtek Medical, Inc. with the FDA for Cupped Forceps.
| Device ID | K833605 | 
| 510k Number | K833605 | 
| Device Name: | CUPPED FORCEPS | 
| Classification | Forceps, Ent | 
| Applicant | MICROTEK MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | KAE | 
| CFR Regulation Number | 874.4420 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1983-10-12 | 
| Decision Date | 1984-01-03 |