510(k) K921243
K921243 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CONVERTORS STERILIZATION WRAP". The FDA issued a decision of Substantially Equivalent on Oct 28, 1992. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 28, 1992
- Date Received
- Mar 13, 1992
- 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)