510(k) K133838
K133838 is an FDA 510(k) premarket notification submitted by Sigma Medical Supplies Corp. for the device "STERILIZATION POUCH/ROLL MADE WITH TYVEK". The FDA issued a decision of Substantially Equivalent on Mar 11, 2015. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Sigma Medical Supplies Corp. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 11, 2015
- Date Received
- Dec 18, 2013
- 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)