510(k) K895422
K895422 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "TOWER SELF SEAL STERILIZATION POUCH". The FDA issued a decision of Substantially Equivalent on Nov 29, 1989. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 29, 1989
- Date Received
- Sep 1, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Indicator, Physical/Chemical Sterilization Process
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type
- 510(k)