510(k) K781228
K781228 is an FDA 510(k) premarket notification submitted by Abco Dealers, Inc. for the device "PENLIGHTS". The FDA issued a decision of Substantially Equivalent on September 7, 1978. The device falls under product code KYT (Light, Examination, Medical, Battery Powered), a Class I device regulated under 21 CFR 880.6350. Abco Dealers, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 1978
- Date Received
- July 17, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Examination, Medical, Battery Powered
- Device Class
- Class I
- Regulation Number
- 880.6350
- Review Panel
- HO
- Submission Type