The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Non-conductive, Single Use Face Mask #55.
| Device ID | K801251 |
| 510k Number | K801251 |
| Device Name: | NON-CONDUCTIVE, SINGLE USE FACE MASK #55 |
| Classification | Mask, Gas, Anesthetic |
| Applicant | VITAL SIGNS, INC. 1 MADISON ST. East Rutherford, NJ 07073 |
| Contact | Terence D Wall |
| Correspondent | Terence D Wall VITAL SIGNS, INC. 1 MADISON ST. East Rutherford, NJ 07073 |
| Product Code | BSJ |
| CFR Regulation Number | 868.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-28 |
| Decision Date | 1980-06-04 |