GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR— 510(k) K050193
Substantially EquivalentLouis M. Gerson Co., Inc.
FDA 510(k) clearance K050193 for GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR, Substantially Equivalent on 2005-04-11. 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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