MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.
FDA 510(k) clearance K052168 · decided 2006-02-16
Clearance details
- K-number
- K052168
- Device name
- MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.
- Applicant
- Medline Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-08-09
- Decision date
- 2006-02-16
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- EZL
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mundelein, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.