The following data is part of a premarket notification filed by Protek, Inc. with the FDA for Day Staple.
| Device ID | K853267 |
| 510k Number | K853267 |
| Device Name: | DAY STAPLE |
| Classification | Staple, Fixation, Bone |
| Applicant | PROTEK, INC. ONE PARK FLETCHER 2601 FORTUNE CIR. E. STE.105B Indianapolis, IN 46241 |
| Contact | Kenneth Epling |
| Correspondent | Kenneth Epling PROTEK, INC. ONE PARK FLETCHER 2601 FORTUNE CIR. E. STE.105B Indianapolis, IN 46241 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-05 |
| Decision Date | 1985-09-06 |