The following data is part of a premarket notification filed by Tecnol Medical Products, Inc. with the FDA for Pfr95 Particulate Filter Respirator And Surgical Mask Regular Size, Pfr95 Particulate Filter Respirator And Surgical.
| Device ID | K974068 |
| 510k Number | K974068 |
| Device Name: | PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL |
| Classification | Respirator, Surgical |
| Applicant | TECNOL MEDICAL PRODUCTS, INC. 7201 INDUSTRIAL PARK BLVD. Fort Worth, TX 76180 |
| Contact | Ruth Jones |
| Correspondent | Ruth Jones TECNOL MEDICAL PRODUCTS, INC. 7201 INDUSTRIAL PARK BLVD. Fort Worth, TX 76180 |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-28 |
| Decision Date | 1997-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 90680651991846 | K974068 | 000 |
| 90680651991815 | K974068 | 000 |
| 90680651991754 | K974068 | 000 |
| 30680651768675 | K974068 | 000 |
| 30680651768279 | K974068 | 000 |
| 30680651767678 | K974068 | 000 |
| 30680651767272 | K974068 | 000 |