The following data is part of a premarket notification filed by Pa Medical Corp. with the FDA for P.a. Medical Vaginal Irrigation Set #1130.
| Device ID | K854595 |
| 510k Number | K854595 |
| Device Name: | P.A. MEDICAL VAGINAL IRRIGATION SET #1130 |
| Classification | Douche Apparatus, Vaginal, Therapeutic |
| Applicant | PA MEDICAL CORP. 1512 NASHVILLE HIGHWAY P.O. BOX 1286 Columbia, TN 38401 |
| Contact | William B Vaughn |
| Correspondent | William B Vaughn PA MEDICAL CORP. 1512 NASHVILLE HIGHWAY P.O. BOX 1286 Columbia, TN 38401 |
| Product Code | HED |
| CFR Regulation Number | 884.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-18 |
| Decision Date | 1986-01-13 |