Atlas FDA

PREP SHAVE KIT (NON-STERILE)

FDA 510(k) clearance K925016 · decided 1993-04-26

Clearance details

K-number
K925016
Device name
PREP SHAVE KIT (NON-STERILE)
Applicant
Customed, Inc.
Decision
Substantially Equivalent
Date received
1992-09-24
Decision date
1993-04-26
Days to decision
214 days
Clearance type
Traditional
Product code
LRO
Device class
2
Regulation number
878.4370
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Fajardo, PR, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Prep shave kit, catalog# 900-030 recall (Z-1253-2012)Customed, Inc2012-03-21