510(k) K921885
- Device
- E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES
- Applicant
- VALLEYLAB, INC.
- 510(k) number
- K921885
- Product code
- HGZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-03-25
- Date received
- 1992-04-21
- Regulation
- 884.5390
- Classification name
- Heater, Perineal, Direct Contact
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PEGGY WALLINE
- Address
- 5920 Longbow Dr. Boulder CO US 80301 80301
FDA Registration Numbers#
- 3039169594
- 3011644607
Source Documents#
Legacy Summary#
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FDA Review#
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