510(k) K840907
K840907 is an FDA 510(k) premarket notification submitted by E.W. Link, Inc. for the device "POST-AID". The FDA issued a decision of Substantially Equivalent on August 2, 1984. The device falls under product code KCM (Dropper, Ent), a Class I device regulated under 21 CFR 874.5220.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 1984
- Date Received
- February 28, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dropper, Ent
- Device Class
- Class I
- Regulation Number
- 874.5220
- Review Panel
- EN
- Submission Type