510(k) K993535
K993535 is an FDA 510(k) premarket notification submitted by Riley Medical, Inc. for the device "METAPAK MULTI-PURPOSE INSTRUMENT TRAY". The FDA issued a decision of Substantially Equivalent on December 7, 2001. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Riley Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 2001
- Date Received
- October 19, 1999
- 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