510(k) K883802
K883802 is an FDA 510(k) premarket notification submitted by James River Corp. for the device "CARETEX CENTRAL SUPPLY WRAP". The FDA issued a decision of Substantially Equivalent on October 21, 1988. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. James River Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 1988
- Date Received
- September 7, 1988
- 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