510(k) K915739
K915739 is an FDA 510(k) premarket notification submitted by Flents Products Co., Inc. for the device "#903 SILAFLEX II". The FDA issued a decision of Substantially Equivalent on June 30, 1992. The device falls under product code EWD (Protector, Hearing (Insert)), a Class U device. Flents Products Co., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 1992
- Date Received
- December 16, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Protector, Hearing (Insert)
- Device Class
- Class U
- Regulation Number
- Review Panel
- EN
- Submission Type