510(k) K923555
K923555 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "CODMAN GAAB NEUROENDOSCOPE". The FDA issued a decision of Substantially Equivalent on March 23, 1993. The device falls under product code GWB (Antisera, Fluorescent, All Types, Streptococcus Pneumoniae), a Class I device regulated under 21 CFR 866.3740. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 1993
- Date Received
- July 17, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Fluorescent, All Types, Streptococcus Pneumoniae
- Device Class
- Class I
- Regulation Number
- 866.3740
- Review Panel
- MI
- Submission Type