510(k) K854159
K854159 is an FDA 510(k) premarket notification submitted by Alcon Laboratories for the device "ELLIPTI-PUNCH". The FDA issued a decision of Substantially Equivalent on November 15, 1985. The device falls under product code FZI (Apparatus, Air Handling, Enclosure), a Class II device regulated under 21 CFR 878.5070. Alcon Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 1985
- Date Received
- October 11, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Air Handling, Enclosure
- Device Class
- Class II
- Regulation Number
- 878.5070
- Review Panel
- SU
- Submission Type