510(k) K913168
K913168 is an FDA 510(k) premarket notification submitted by Nix Co. , Ltd. for the device "SALIBAG". The FDA issued a decision of Substantially Equivalent on September 6, 1991. The device falls under product code EGZ (Holder, Film, X-Ray), a Class I device regulated under 21 CFR 872.1905. Nix Co. , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 6, 1991
- Date Received
- July 17, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holder, Film, X-Ray
- Device Class
- Class I
- Regulation Number
- 872.1905
- Review Panel
- DE
- Submission Type