FDA 510(k) Premarket Notification K102092: PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES

Submission Details & Decision

Normalized public record details for 510(k) notification K102092.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K102092

Applicant / Sponsor

Prestige Ameritech

Device Name

PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES

Product Code

MSH

Decision Date

2010-10-06

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

General, Plastic Surgery (SU)

Clearance Type

Abbreviated

Third Party Flag

Date Received

2010-07-27

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