STERILE SUTURE REMOVAL KIT— 510(k) K925015
UnknownCustomed, Inc.
FDA 510(k) clearance K925015 for STERILE SUTURE REMOVAL KIT, Unknown on 1993-06-07. Applicant: Customed, Inc.. Device class: 1.
Clearance details
- Applicant
- Customed, Inc.
- Product code
- Code MCZ
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Fajardo, PR, US
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Recalls naming K925015
K-number listed on FDA's recall record- Z-1398-2016 — Catalog Number: 900010 SUTURE REMOVAL KIT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-2549-2015 — SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K925015.
Data sourced from openFDA. This site is unofficial and independent of the FDA.