The following data is part of a premarket notification filed by J. Sklar Mfg. Co., Inc. with the FDA for Kevorkian-younge Biopsy Curette #90-6611.
| Device ID | K802458 |
| 510k Number | K802458 |
| Device Name: | KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611 |
| Classification | Forceps, Biopsy, Gynecological |
| Applicant | J. SKLAR MFG. CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HFB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-08 |
| Decision Date | 1981-01-12 |