TRAY, CATHETERIZATION W/O CATHETER
FDA 510(k) clearance K760127 · decided 1976-10-07
Clearance details
- K-number
- K760127
- Device name
- TRAY, CATHETERIZATION W/O CATHETER
- Applicant
- Concord Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-06-28
- Decision date
- 1976-10-07
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- FCM
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.