The following data is part of a premarket notification filed by Hct, Inc. with the FDA for Villalta Retractor.
| Device ID | K943875 |
| 510k Number | K943875 |
| Device Name: | VILLALTA RETRACTOR |
| Classification | Retractor |
| Applicant | HCT, INC. 6443 WEST 10TH ST. SUITE 202 Indianapolis, IN 46214 |
| Contact | Michael L Einterz |
| Correspondent | Michael L Einterz HCT, INC. 6443 WEST 10TH ST. SUITE 202 Indianapolis, IN 46214 |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-08 |
| Decision Date | 1994-11-09 |