510(k) K760846
K760846 is an FDA 510(k) premarket notification submitted by Pako Corp. for the device "PAKOSTAT II". The FDA issued a decision of Substantially Equivalent on January 7, 1977. The device falls under product code EGW (Dryer, Film, Radiographic), a Class II device regulated under 21 CFR 892.1900.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 1977
- Date Received
- October 15, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dryer, Film, Radiographic
- Device Class
- Class II
- Regulation Number
- 892.1900
- Review Panel
- RA
- Submission Type