REPLACEMENT BATTERIES— 510(k) K943632
Substantially EquivalentNational Custom Ent., Inc.
FDA 510(k) clearance K943632 for REPLACEMENT BATTERIES, Substantially Equivalent on 1994-11-04. Applicant: National Custom Ent., Inc.. Device class: 1.
Clearance details
- Applicant
- National Custom Ent., Inc.
- Product code
- Code FCO
- Device class
- Class 1
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burnsville, MN, US
Recent devices under product code FCO
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- K012262 — BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC
- K012266 — SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2
Data sourced from openFDA. This site is unofficial and independent of the FDA.