The following data is part of a premarket notification filed by Custom Medical Products, Ltd. with the FDA for Aperture.
Device ID | K895084 |
510k Number | K895084 |
Device Name: | APERTURE |
Classification | Aperture, Radiographic |
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 | IZS |
CFR Regulation Number | 892.1610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-14 |
Decision Date | 1989-10-27 |