FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE
K Number: K082674
·
Decision Nov 28, 2008
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
6
Review Days
74
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Basic Information
- Device Name
- SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE
- K Number
- K082674
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Spectra Medical Devices, Inc.
- Date Received
- September 15, 2008
- Decision Date
- November 28, 2008
- Product Code
- FMF
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
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Other Clearances by Spectra Medical Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K151069 | SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle | Feb 5, 2016 | Substantially Equivalent |
| K103740 | SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE | Jul 29, 2011 | Substantially Equivalent |
| K082689 | STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE | Mar 20, 2009 | Substantially Equivalent |
| K082580 | SPECTRA GUIDEWIRE INTRODUCER NEEDLE | Dec 8, 2008 | Substantially Equivalent |
| K081524 | SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L | Jul 29, 2008 | Substantially Equivalent |