The following data is part of a premarket notification filed by Custom Medical Products, Ltd. with the FDA for Mamm-aire Cp.
| Device ID | K893681 |
| 510k Number | K893681 |
| Device Name: | MAMM-AIRE CP |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | CUSTOM MEDICAL PRODUCTS, LTD. 19A WEST INDUSTRY COURT Deer Park, NY 11729 |
| Contact | James Collette |
| Correspondent | James Collette CUSTOM MEDICAL PRODUCTS, LTD. 19A WEST INDUSTRY COURT Deer Park, NY 11729 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-16 |
| Decision Date | 1989-07-20 |