The following data is part of a premarket notification filed by Medical Action Industries, Inc. with the FDA for Vaginal Speculum, Model 5555s, 5555m, Or 5555l.
| Device ID | K022948 |
| 510k Number | K022948 |
| Device Name: | VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | MEDICAL ACTION INDUSTRIES, INC. 2 SUMMIRT DR. Arden, NC 28704 |
| Contact | Sharon Suess Graham |
| Correspondent | Sharon Suess Graham MEDICAL ACTION INDUSTRIES, INC. 2 SUMMIRT DR. Arden, NC 28704 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-05 |
| Decision Date | 2002-11-04 |
| Summary: | summary |