510(k) K821177
K821177 is an FDA 510(k) premarket notification submitted by Abco Dealers, Inc. for the device "BITE STICK". The FDA issued a decision of Substantially Equivalent on May 21, 1982. The device falls under product code FMA (Depressor, Tongue, Non-Surgical), a Class I device regulated under 21 CFR 880.6230. Abco Dealers, Inc. has 126 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 1982
- Date Received
- Apr 27, 1982
- 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
- 510(k) Exempt