PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL— 510(k) K974068
Substantially EquivalentTecnol Medical Products, Inc.
FDA 510(k) clearance K974068 for PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL, Substantially Equivalent on 1997-12-22. Applicant: Tecnol Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Tecnol Medical Products, Inc.
- Product code
- Code MSH
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Worth, TX, US
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More clearances from Tecnol Medical Products, Inc.
view allRecalls naming K974068
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K974068.
Data sourced from openFDA. This site is unofficial and independent of the FDA.