The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Gaab Neuroendoscope.
Device ID | K923555 |
510k Number | K923555 |
Device Name: | CODMAN GAAB NEUROENDOSCOPE |
Classification | Antisera, Fluorescent, All Types, Streptococcus Pneumoniae |
Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
Contact | Nancy Adelstein |
Correspondent | Nancy Adelstein Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
Product Code | GWB |
CFR Regulation Number | 866.3740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-17 |
Decision Date | 1993-03-23 |