510(k) K850437
- Device
- DISPOSABLE LARYNGOSCOPE
- Applicant
- VITAL SIGNS, INC.
- 510(k) number
- K850437
- Product code
- LLW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-02-14
- Date received
- 1985-02-05
- Regulation
- 884.4550
- Classification name
- Laser, Neodymium:yag For Gynecologic Use
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- TERENCE D WALL
- Address
- 20 Campus Rd. Totowa NJ US 07512 07512
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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