The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Hemo-wedge.
| Device ID | K790555 |
| 510k Number | K790555 |
| Device Name: | HEMO-WEDGE |
| Classification | Instruments, Dental Hand |
| Applicant | PARKER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DZN |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-19 |
| Decision Date | 1980-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E29950300 | K790555 | 000 |
| E29950250 | K790555 | 000 |
| E29950249 | K790555 | 000 |
| E29950239 | K790555 | 000 |
| E29950229 | K790555 | 000 |
| E29950219 | K790555 | 000 |
| E29950209 | K790555 | 000 |