The following data is part of a premarket notification filed by Effner And Spreine Co. with the FDA for Effner Sims Rectal Speculum W/fiber Optic Illumina.
| Device ID | K852014 |
| 510k Number | K852014 |
| Device Name: | EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA |
| Classification | Surgical Instruments, G-u, Manual (and Accessories) |
| Applicant | EFFNER AND SPREINE CO. P.O. BOX 191 Port Washington, NY 11050 |
| Contact | Emmanuel Anapliotis |
| Correspondent | Emmanuel Anapliotis EFFNER AND SPREINE CO. P.O. BOX 191 Port Washington, NY 11050 |
| Product Code | KOA |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-09 |
| Decision Date | 1985-08-07 |