The following data is part of a premarket notification filed by Berkley Medical Resources, Inc. with the FDA for Floor Mask-ear Loop(bmr-15011)/floor Mask-tie(bmr-1503).
| Device ID | K971744 |
| 510k Number | K971744 |
| Device Name: | FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503) |
| Classification | Mask, Surgical |
| Applicant | BERKLEY MEDICAL RESOURCES, INC. 31 INNSBROOK RD. Ashville, NC 28804 |
| Contact | Frank R Dastoli |
| Correspondent | Frank R Dastoli BERKLEY MEDICAL RESOURCES, INC. 31 INNSBROOK RD. Ashville, NC 28804 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-12 |
| Decision Date | 1997-07-28 |