510(k) K972867
- Device
- CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT
- Applicant
- ROCKET MEDICAL PLC
- 510(k) number
- K972867
- Product code
- ICX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-10-24
- Date received
- 1997-08-04
- Regulation
- 864.1850
- Classification name
- Aniline
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- L TODD
- Address
- Factories 3 & 4, Wear Industrial Estate Washington, Tyne & Wear GB NE37 1NE NE37 1NE
FDA Registration Numbers#
- 1219125
- 3008174888
Source Documents#
Legacy Summary#
summary
FDA Review#
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