510(k) K992995
K992995 is an FDA 510(k) premarket notification submitted by Aga Plastic Ind. Com. Ltda. for the device "AROMATIC AND FLAVORED TONGUE DEPRESSOR". The FDA issued a decision of Substantially Equivalent on December 9, 1999. The device falls under product code FMA (Depressor, Tongue, Non-Surgical), a Class I device regulated under 21 CFR 880.6230. Aga Plastic Ind. Com. Ltda. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1999
- Date Received
- September 7, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Depressor, Tongue, Non-Surgical
- Device Class
- Class I
- Regulation Number
- 880.6230
- Review Panel
- HO
- Submission Type