510(k) K923555
- Device
- CODMAN GAAB NEUROENDOSCOPE
- Applicant
- Codman & Shurtleff, Inc.
- 510(k) number
- K923555
- Product code
- GWB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-03-23
- Date received
- 1992-07-17
- Regulation
- 866.3740
- Classification name
- Antisera, Fluorescent, All Types, Streptococcus Pneumoniae
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NANCY ADELSTEIN
- Address
- 41 Pacella Park Dr. Randolph Industrial Park Randolph MA US 02368 02368
Source Documents#
Other 510(k) Records For Product Code GWB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K760816 | PNEUMOTACHOGRAPHY SYSTEM | Aftercal, Inc. | 1976-10-29 |
Legacy Summary#
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FDA Review#
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