510(k) K951704
K951704 is an FDA 510(k) premarket notification submitted by Products For Medicine for the device "NON-WOVEN FILTER PAPER FOR STEAM AND GAS STERILIZATION". The FDA issued a decision of Substantially Equivalent on June 28, 1995. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Products For Medicine has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 1995
- Date Received
- April 12, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wrap, Sterilization
- Device Class
- Class II
- Regulation Number
- 880.6850
- Review Panel
- HO
- Submission Type