The following data is part of a premarket notification filed by Ar Custom Medical Products, Ltd. with the FDA for Mamm-aire.
| Device ID | K863890 |
| 510k Number | K863890 |
| Device Name: | MAMM-AIRE |
| Classification | Cradle, Patient, Radiologic |
| Applicant | AR CUSTOM MEDICAL PRODUCTS, LTD. 19A WEST INDUSTRY COURT Deer Park, NY 11729 |
| Contact | James Collette |
| Correspondent | James Collette AR CUSTOM MEDICAL PRODUCTS, LTD. 19A WEST INDUSTRY COURT Deer Park, NY 11729 |
| Product Code | KXH |
| CFR Regulation Number | 892.1830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-06 |
| Decision Date | 1986-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850306007599 | K863890 | 000 |
| 00850306007582 | K863890 | 000 |
| 00850306007575 | K863890 | 000 |
| 00850306007551 | K863890 | 000 |
| 00850306007544 | K863890 | 000 |
| 00850306007537 | K863890 | 000 |
| 00850306007605 | K863890 | 000 |