510(k) K934548
- Device
- ALL-VUE & GAMMA-VUE VIAL SHIELDS
- Applicant
- VICTOREEN, INC.
- 510(k) number
- K934548
- Product code
- IWW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-11-12
- Date received
- 1993-09-22
- Regulation
- 892.6500
- Classification name
- Shield, Vial
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRISTINE L JESS
- Address
- 6000 Cochran Rd. Cleveland OH US 44130 44130
FDA Registration Numbers#
- 3016739098
- 3009140376
- 2518443
- 3007369190
- 3020824984
- 3013070673
- 8022029
- 1225473
- 3009088444
- 2411512
- 3012690638
- 3005579300
- 3012314549
- 3008627763
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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