RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730— 510(k) K061375
Substantially EquivalentLouis M. Gerson Co., Inc.
FDA 510(k) clearance K061375 for RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730, Substantially Equivalent on 2006-11-17. Applicant: Louis M. Gerson Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Louis M. Gerson Co., 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
- Middleboro, MA, US
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