510(k) K780287
K780287 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "DAY HEAR HOOK". The FDA issued a decision of Substantially Equivalent on February 27, 1978. The device falls under product code JYL (Hook, Microsurgical Ear), a Class I device regulated under 21 CFR 874.4420. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 1978
- Date Received
- February 21, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hook, Microsurgical Ear
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type