510(k) K952691
- Device
- WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT
- Applicant
- WELCH ALLYN, INC.
- 510(k) number
- K952691
- Product code
- FJC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-07-31
- Date received
- 1995-06-12
- Regulation
- 876.5820
- Classification name
- Detector, Blood Level
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY KAY TESORO
- Address
- 4341 State St. Rd. P.O. Box 220 Skaneateles Falls NY US 13153 13153
Source Documents#
Legacy Summary#
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FDA Review#
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