The following data is part of a premarket notification filed by Howard Medical Co. with the FDA for Or Specialties Vaginal Pack.
| Device ID | K820195 |
| 510k Number | K820195 |
| Device Name: | OR SPECIALTIES VAGINAL PACK |
| Classification | Gauze/sponge, Internal |
| Applicant | HOWARD MEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-25 |
| Decision Date | 1982-03-05 |