The following data is part of a premarket notification filed by Debusk Knitting Mills, Div. Deroyal Industries with the FDA for Deroyal Industries Infant Heel Warmer.
| Device ID | K954716 |
| 510k Number | K954716 |
| Device Name: | DEROYAL INDUSTRIES INFANT HEEL WARMER |
| Classification | Infant Heel Warmer (chemical Heat Pack) |
| Applicant | DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | MPO |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-13 |
| Decision Date | 1996-01-11 |