The following data is part of a premarket notification filed by Innovative Gynecological Solutions Llc with the FDA for Igs Vaginal Speculum.
| Device ID | K060129 |
| 510k Number | K060129 |
| Device Name: | IGS VAGINAL SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | INNOVATIVE GYNECOLOGICAL SOLUTIONS LLC 5 WENTWORTH DRIVE Hudson, NH 03051 |
| Contact | Joseph P Paolo |
| Correspondent | Joseph P Paolo INNOVATIVE GYNECOLOGICAL SOLUTIONS LLC 5 WENTWORTH DRIVE Hudson, NH 03051 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-18 |
| Decision Date | 2006-05-04 |
| Summary: | summary |