510(k) K180139
K180139 is an FDA 510(k) premarket notification submitted by Safe Secure Packing Co., Ltd. for the device "Safe Secure Sterilization Pouches and Rolls". The FDA issued a decision of Substantially Equivalent on Jan 3, 2019. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 3, 2019
- Date Received
- Jan 18, 2018
- 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)