510(k) K921461
- Device
- TURKEL THORACENTESIS NEEDLE
- Applicant
- SYMBIOSIS CORP.
- 510(k) number
- K921461
- Product code
- GSS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-07-30
- Date received
- 1992-03-27
- Regulation
- 866.3415
- Classification name
- Antisera, Fluorescent, Pseudomonas Aeruginosa
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEVIN W SMITH
- Address
- 8600 NW 41 St. Miami FL US 33166 33166
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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