The following data is part of a premarket notification filed by Shanghai Intco Medical Supply Co., Ltd. with the FDA for Infant Heel Warmer By Intco.
| Device ID | K053254 |
| 510k Number | K053254 |
| Device Name: | INFANT HEEL WARMER BY INTCO |
| Classification | Infant Heel Warmer (chemical Heat Pack) |
| Applicant | SHANGHAI INTCO MEDICAL SUPPLY CO., LTD. 12390 EAST END AVENUE Chino, CA 91710 |
| Contact | John Zhao |
| Correspondent | John Zhao SHANGHAI INTCO MEDICAL SUPPLY CO., LTD. 12390 EAST END AVENUE Chino, CA 91710 |
| Product Code | MPO |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-21 |
| Decision Date | 2006-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10849027001808 | K053254 | 000 |
| 20612479191208 | K053254 | 000 |
| 10818566017618 | K053254 | 000 |
| 00860008614605 | K053254 | 000 |
| 00850046230103 | K053254 | 000 |
| 00850046230097 | K053254 | 000 |