510(k) K954716
K954716 is an FDA 510(k) premarket notification submitted by Debusk Knitting Mills, Div. Deroyal Industries for the device "DEROYAL INDUSTRIES INFANT HEEL WARMER". The FDA issued a decision of Substantially Equivalent on January 11, 1996. The device falls under product code MPO (Infant Heel Warmer (Chemical Heat Pack)), a Class I device regulated under 21 CFR 890.5710. Debusk Knitting Mills, Div. Deroyal Industries has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 1996
- Date Received
- October 13, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Infant Heel Warmer (Chemical Heat Pack)
- Device Class
- Class I
- Regulation Number
- 890.5710
- Review Panel
- PM
- Submission Type