PCM 2000; ISOLAIR APR MODEL 2735— 510(k) K970448
Substantially EquivalentTecnol Medical Products, Inc.
FDA 510(k) clearance K970448 for PCM 2000; ISOLAIR APR MODEL 2735, Substantially Equivalent on 1997-04-30. 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 all- K974068 — PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL
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- K963559 — WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)
- K963564 — PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)
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Data sourced from openFDA. This site is unofficial and independent of the FDA.