The following data is part of a premarket notification filed by Cypress Medical Products, Ltd. with the FDA for Isosafe Earloop Procedure Mask (blue, Yellow).
| Device ID | K972883 |
| 510k Number | K972883 |
| Device Name: | ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) |
| Classification | Mask, Surgical |
| Applicant | CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
| Contact | Anthony L Giaccio |
| Correspondent | Anthony L Giaccio CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-05 |
| Decision Date | 1998-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40612479257205 | K972883 | 000 |
| 40612479257458 | K972883 | 000 |