510(k) K900218
- Device
- J&S HDL CHOLESTEROL PRECIPITATING REAGENT
- Applicant
- J.S. MEDICAL ASSOC.
- 510(k) number
- K900218
- Product code
- LBL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-06-18
- Date received
- 1990-01-17
- Regulation
- 874.3880
- Classification name
- Tube, Tympanostomy, Porous Polyethylene
- Medical specialty
- Ear Nose & Throat
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARSHALL E DEUTSCH
- Address
- 19 Strathmore Rd. Natick MA US 01760 01760
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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