510(k) K862241
K862241 is an FDA 510(k) premarket notification submitted by Quali-Med, Inc. for the device "STANDARD BASIN KIT CUSTOM BASIN KIT". The FDA issued a decision of Substantially Equivalent on Aug 1, 1986. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Quali-Med, Inc. has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 1, 1986
- Date Received
- Jun 12, 1986
- 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
- 510(k)