The following data is part of a premarket notification filed by Prism Enterprises, Inc. with the FDA for Mityview 4-way Lateral Expander Speculum.
| Device ID | K000444 |
| 510k Number | K000444 |
| Device Name: | MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | PRISM ENTERPRISES, INC. 10 AUBREY COURT San Antonio, TX 78216 |
| Contact | Judith A Harbour |
| Correspondent | Judith A Harbour PRISM ENTERPRISES, INC. 10 AUBREY COURT San Antonio, TX 78216 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-10 |
| Decision Date | 2000-04-21 |