The following data is part of a premarket notification filed by Patton Medical Corp. with the FDA for Patton Speculum.
| Device ID | K991963 |
| 510k Number | K991963 |
| Device Name: | PATTON SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | PATTON MEDICAL CORP. 1000 WESTBANK DR. SUITE 5A200 Austin, TX 78746 |
| Contact | Michael T Patton |
| Correspondent | Michael T Patton PATTON MEDICAL CORP. 1000 WESTBANK DR. SUITE 5A200 Austin, TX 78746 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-10 |
| Decision Date | 1999-09-01 |
| Summary: | summary |