The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Single And Double Lumen Skull Bolt Kits.
Device ID | K992591 |
510k Number | K992591 |
Device Name: | CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS |
Classification | Device, Monitoring, Intracranial Pressure |
Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Contact | James M Flaherty |
Correspondent | James M Flaherty Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Product Code | GWM |
CFR Regulation Number | 882.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-02 |
Decision Date | 1999-10-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10886704042501 | K992591 | 000 |