510(k) K801065
- Device
- Nikkiso Parallel Flow Dialyzers
- Applicant
- INT'L MARKETING & SALES CORP.
- 510(k) number
- K801065
- Product code
- FTG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-08-07
- Date received
- 1980-05-06
- Regulation
- 878.4580
- Classification name
- Illuminator, Remote
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3017482216
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FTG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K760815 | FITTING/DIALYZER | Cobe Laboratories, Inc. | 1976-11-19 |