510(k) K953277
K953277 is an FDA 510(k) premarket notification submitted by Fatswith Intl., Inc. for the device "SHADOW MEDAL LOCATOR". The FDA issued a decision of Substantially Equivalent on April 1, 1996. The device falls under product code HPM (Locator, Metal, Electronic), a Class II device regulated under 21 CFR 886.4400.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 1996
- Date Received
- July 13, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Locator, Metal, Electronic
- Device Class
- Class II
- Regulation Number
- 886.4400
- Review Panel
- OP
- Submission Type