The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for The Cabot Medical Insul-sheth Vaginal Speculum Cov.
| Device ID | K930954 |
| 510k Number | K930954 |
| Device Name: | THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Contact | Todd J Polk |
| Correspondent | Todd J Polk CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-23 |
| Decision Date | 1994-06-30 |