510(k) K884974
K884974 is an FDA 510(k) premarket notification submitted by Suredrop, Inc. for the device "ACCESSORY TO EYEDROP GUIDE". The FDA issued a decision of Substantially Equivalent on March 24, 1989. The device falls under product code JYJ (Gauge, Measuring), a Class I device regulated under 21 CFR 874.4420. Suredrop, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 1989
- Date Received
- November 30, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gauge, Measuring
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type