The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Disposable Perforator.
Device ID | K933894 |
510k Number | K933894 |
Device Name: | DISPOSABLE PERFORATOR |
Classification | Drills, Burrs, Trephines & Accessories (compound, Powered) |
Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
Contact | Amy Walters |
Correspondent | Amy Walters Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
Product Code | HBF |
CFR Regulation Number | 882.4305 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-10 |
Decision Date | 1993-12-10 |
Summary: | summary |