510(k) K043301
K043301 is an FDA 510(k) premarket notification submitted by GC America, Inc. for the device "GC TION GINGIVAL PROTECTOR". The FDA issued a decision of Substantially Equivalent on January 25, 2005. The device falls under product code EIE (Dam, Rubber), a Class I device regulated under 21 CFR 872.6300. GC America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 2005
- Date Received
- November 30, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dam, Rubber
- Device Class
- Class I
- Regulation Number
- 872.6300
- Review Panel
- DE
- Submission Type