The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Disposable Perforators, Jacobs, Hudson.
| Device ID | K791101 |
| 510k Number | K791101 |
| Device Name: | DISPOSABLE PERFORATORS, JACOBS, HUDSON |
| Classification | Drills, Burrs, Trephines & Accessories (compound, Powered) |
| Applicant | Codman & Shurtleff, Inc. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HBF |
| CFR Regulation Number | 882.4305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-13 |
| Decision Date | 1979-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780513599 | K791101 | 000 |
| 10886704005100 | K791101 | 000 |