510(k) K964256
K964256 is an FDA 510(k) premarket notification submitted by Madison Polymeric Engineering for the device "CYGNUS INSTRUMENT PROTECTORS". The FDA issued a decision of Substantially Equivalent on May 6, 1997. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Madison Polymeric Engineering has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 1997
- Date Received
- October 25, 1996
- 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