510(k) K913527
- Device
- HYPERFREE
- Applicant
- Kist Intl.
- 510(k) number
- K913527
- Product code
- BYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-01-21
- Date received
- 1991-08-08
- Regulation
- 868.5220
- Classification name
- Bottle, Blow
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- LEONARD NIHAN
- Address
- 550 Lisbon St. Lewiston ME US 04240 04240
FDA Registration Numbers#
- 3005273623
- 3011659880
- 3013530901
- 3017357127
Source Documents#
510(k) summary PDF not indicated by FDA