The following data is part of a premarket notification filed by Tecnol Medical Products, Inc. with the FDA for Tecnol Pcm 2000.
| Device ID | K932834 |
| 510k Number | K932834 |
| Device Name: | TECNOL PCM 2000 |
| Classification | Mask, Surgical |
| Applicant | TECNOL MEDICAL PRODUCTS, INC. 7201 INDUSTRIAL PARK BLVD. Fort Worth, TX 76180 |
| Contact | Leona Hammel |
| Correspondent | Leona Hammel TECNOL MEDICAL PRODUCTS, INC. 7201 INDUSTRIAL PARK BLVD. Fort Worth, TX 76180 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-10 |
| Decision Date | 1994-05-03 |