510(k) K941574
K941574 is an FDA 510(k) premarket notification submitted by Union Broach, Div. Moyco Industries, Inc. for the device "RETRO MIRROR". The FDA issued a decision of Substantially Equivalent on May 18, 1994. The device falls under product code EAX (Mirror, Mouth), a Class I device regulated under 21 CFR 872.4565. Union Broach, Div. Moyco Industries, Inc. has 13 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 1994
- Date Received
- Mar 31, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mirror, Mouth
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type
- 510(k) Exempt