DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF— 510(k) K872006
Substantially EquivalentMac Lee Medical Products
FDA 510(k) clearance K872006 for DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF, Substantially Equivalent on 1987-11-17. Applicant: Mac Lee Medical Products. Device class: 2.
Clearance details
- Applicant
- Mac Lee Medical Products
- Product code
- Code FGD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Topeka, KS, US
Recent devices under product code FGD
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