510(k) K770084
- Device
- OPERATING ROOM VENTILATOR
- Applicant
- Dupaco, Inc.
- 510(k) number
- K770084
- Product code
- FZH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-02-23
- Date received
- 1977-01-14
- Regulation
- 878.5070
- Classification name
- Apparatus, Air Handling, Room
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3025585194
- 1833506
- 3015526568
- 3014151865
Source Documents#
510(k) summary PDF not indicated by FDA