Submission Details
| 510(k) Number | K973497 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 15, 1997 |
| Decision Date | January 13, 1998 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
K973497 - HUBERLOC
(FDA 510(k) Clearance)
Jan 1998
Decision
120d
Days
Class 2
Risk
K973497 is an FDA 510(k) clearance for the HUBERLOC, a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II — Special Controls, product code LJT), submitted by Medcare Medical Group, Inc. (East Swanzey, US). The FDA issued a Cleared decision on January 13, 1998, 120 days after receiving the submission on September 15, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.
Device Classification
| Product Code | LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5965 |
Similar Devices — LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
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