510(k) K891247
K891247 is an FDA 510(k) premarket notification submitted by Siemens Hearing Instruments, Inc. for the device "BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC". The FDA issued a decision of Substantially Equivalent on March 29, 1989. The device falls under product code ESF (Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent), a Class II device regulated under 21 CFR 878.3500. Siemens Hearing Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 1989
- Date Received
- March 8, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
- Device Class
- Class II
- Regulation Number
- 878.3500
- Review Panel
- SU
- Submission Type