The following data is part of a premarket notification filed by Kolplast Comercial E Industrial Ltda with the FDA for Kolplast Vaginal Speculum.
| Device ID | K973853 |
| 510k Number | K973853 |
| Device Name: | KOLPLAST VAGINAL SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | KOLPLAST COMERCIAL E INDUSTRIAL LTDA P.O BOX 4341 Crofton, MD 21114 |
| Contact | E J Smith |
| Correspondent | E J Smith KOLPLAST COMERCIAL E INDUSTRIAL LTDA P.O BOX 4341 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 | 1997-10-08 |
| Decision Date | 1997-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07898027903519 | K973853 | 000 |
| 07898027904127 | K973853 | 000 |
| 07898027904110 | K973853 | 000 |
| 07898027903687 | K973853 | 000 |
| 07898027903663 | K973853 | 000 |
| 07898027903656 | K973853 | 000 |
| 07898027903038 | K973853 | 000 |
| 07898027902161 | K973853 | 000 |
| 07898027902154 | K973853 | 000 |
| 07898027905988 | K973853 | 000 |
| 07898027906015 | K973853 | 000 |
| 07898027909108 | K973853 | 000 |
| 07898027907951 | K973853 | 000 |
| 07898027907333 | K973853 | 000 |
| 07898027907326 | K973853 | 000 |
| 07898027907166 | K973853 | 000 |
| 07898027907159 | K973853 | 000 |
| 07898027907074 | K973853 | 000 |
| 07898027906312 | K973853 | 000 |
| 07898027902130 | K973853 | 000 |