The following data is part of a premarket notification filed by Alpha Pro Tech, Inc. with the FDA for Facelock Filter Mask.
| Device ID | K890128 |
| 510k Number | K890128 |
| Device Name: | FACELOCK FILTER MASK |
| Classification | Mask, Surgical |
| Applicant | ALPHA PRO TECH, INC. 6102 SOUTH MEMORIAL Tulsa, OK 74133 |
| Contact | W. C Klintworth |
| Correspondent | W. C Klintworth ALPHA PRO TECH, INC. 6102 SOUTH MEMORIAL Tulsa, OK 74133 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-12 |
| Decision Date | 1989-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817583020649 | K890128 | 000 |
| 30817583020018 | K890128 | 000 |
| 20817583020028 | K890128 | 000 |
| 20817583020035 | K890128 | 000 |
| 20817583020042 | K890128 | 000 |
| 20817583020059 | K890128 | 000 |
| 20817583020066 | K890128 | 000 |
| 20817583020073 | K890128 | 000 |
| 20817583020080 | K890128 | 000 |
| 20817583020097 | K890128 | 000 |
| 20817583020103 | K890128 | 000 |
| 20817583020110 | K890128 | 000 |
| 20817583020622 | K890128 | 000 |
| H816PFL0082 | K890128 | 000 |
| H816PFLEL82 | K890128 | 000 |
| 10817583020632 | K890128 | 000 |
| H816MPFL0082 | K890128 | 000 |