The following data is part of a premarket notification filed by Panatrex, Inc. with the FDA for Vag O Speculum, Models Vs1, Vm1, Vl1.
| Device ID | K042950 |
| 510k Number | K042950 |
| Device Name: | VAG O SPECULUM, MODELS VS1, VM1, VL1 |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | PANATREX, INC. 1648 SIERRA MADRE CIR. Placentia, CA 92870 -6626 |
| Contact | Kevin Kuo |
| Correspondent | Kevin Kuo PANATREX, INC. 1648 SIERRA MADRE CIR. Placentia, CA 92870 -6626 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-26 |
| Decision Date | 2004-11-30 |
| Summary: | summary |