The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Speculum, Vaginal, Nonmetal.
| Device ID | K120743 |
| 510k Number | K120743 |
| Device Name: | SPECULUM, VAGINAL, NONMETAL |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Kevin Crossen |
| Correspondent | Kevin Crossen WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-12 |
| Decision Date | 2012-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094239140 | K120743 | 000 |
| 00732094236453 | K120743 | 000 |
| 00732094221978 | K120743 | 000 |
| 00732094236033 | K120743 | 000 |
| 00732094236040 | K120743 | 000 |
| 00732094236460 | K120743 | 000 |
| 00732094236057 | K120743 | 000 |
| 00732094236088 | K120743 | 000 |
| 00732094222296 | K120743 | 000 |
| 00732094236064 | K120743 | 000 |