The following data is part of a premarket notification filed by Dynascend Consulting Int'l Llc. with the FDA for Global Healthcare Vaginal Speculum.
| Device ID | K013835 |
| 510k Number | K013835 |
| Device Name: | GLOBAL HEALTHCARE VAGINAL SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | DYNASCEND CONSULTING INT'L LLC. 1144 CANTON ST., SUITE 103 Roswell, GA 30075 |
| Contact | Alam Ahmed |
| Correspondent | Alam Ahmed DYNASCEND CONSULTING INT'L LLC. 1144 CANTON ST., SUITE 103 Roswell, GA 30075 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-19 |
| Decision Date | 2002-01-17 |