510(k) K842670
K842670 is an FDA 510(k) premarket notification submitted by Advanced Biomedical Instruments for the device "BIOLAS YAG 100". The FDA issued a decision of Substantially Equivalent on August 8, 1984. Advanced Biomedical Instruments has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 1984
- Date Received
- July 10, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No