The following data is part of a premarket notification filed by Artiberia with the FDA for 53-100 To 53-120 Various Rectal Specula(sims, Math.
| Device ID | K851797 |
| 510k Number | K851797 |
| Device Name: | 53-100 TO 53-120 VARIOUS RECTAL SPECULA(SIMS, MATH |
| Classification | Speculum, Rectal |
| Applicant | ARTIBERIA 4518 LOS RANCHITOS San Antonio, TX 78233 |
| Contact | Gil M Sanchez |
| Correspondent | Gil M Sanchez ARTIBERIA 4518 LOS RANCHITOS San Antonio, TX 78233 |
| Product Code | FFQ |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-25 |
| Decision Date | 1985-05-23 |