510(k) K973981
K973981 is an FDA 510(k) premarket notification submitted by Adroit Medical Systems, Inc. for the device "SAFEPASS STERILIZATION POUCH". The FDA issued a decision of Substantially Equivalent on January 29, 1998. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Adroit Medical Systems, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 1998
- Date Received
- October 20, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device Class
- Class II
- Regulation Number
- 880.6850
- Review Panel
- HO
- Submission Type