The following data is part of a premarket notification filed by Simpson/basye, Inc. with the FDA for Marlow Anal Speculum.
| Device ID | K891352 |
| 510k Number | K891352 |
| Device Name: | MARLOW ANAL SPECULUM |
| Classification | Surgical Instruments, G-u, Manual (and Accessories) |
| Applicant | SIMPSON/BASYE, INC. 430 AYRE ST. Wilmington, DE 19804 |
| Contact | Robert A Basye |
| Correspondent | Robert A Basye SIMPSON/BASYE, INC. 430 AYRE ST. Wilmington, DE 19804 |
| Product Code | KOA |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-10 |
| Decision Date | 1989-06-23 |