510(k) K881371
K881371 is an FDA 510(k) premarket notification submitted by Cox Sterile Products, Inc. for the device "COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE". The FDA issued a decision of Substantially Equivalent on April 13, 1988. The device falls under product code KMH (Sterilizer, Dry Heat), a Class II device regulated under 21 CFR 880.6870. Cox Sterile Products, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 1988
- Date Received
- April 1, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Dry Heat
- Device Class
- Class II
- Regulation Number
- 880.6870
- Review Panel
- HO
- Submission Type