The following data is part of a premarket notification filed by Kolplast Ci Ltda with the FDA for Kolplux System.
| Device ID | K110766 |
| 510k Number | K110766 |
| Device Name: | KOLPLUX SYSTEM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | KOLPLAST CI LTDA 1468 Harwell Avenue Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith KOLPLAST CI LTDA 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-18 |
| Decision Date | 2011-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07898027903526 | K110766 | 000 |