The following data is part of a premarket notification filed by Epimed International, Inc. with the FDA for Flexible Introducer Cannula, Model 135-1837.
| Device ID | K051860 |
| 510k Number | K051860 |
| Device Name: | FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 |
| Classification | Needle, Spinal, Short Term |
| Applicant | EPIMED INTERNATIONAL, INC. 141 SAL LANDRIO DR. CROSSROADS BUSINESS PARK Johnstown, NY 12095 |
| Contact | Christopher Lake |
| Correspondent | Christopher Lake EPIMED INTERNATIONAL, INC. 141 SAL LANDRIO DR. CROSSROADS BUSINESS PARK Johnstown, NY 12095 |
| Product Code | MIA |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-08 |
| Decision Date | 2005-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818788021004 | K051860 | 000 |
| 10818788020892 | K051860 | 000 |
| 10818788020908 | K051860 | 000 |
| 10818788020915 | K051860 | 000 |
| 10818788020922 | K051860 | 000 |
| 10818788020939 | K051860 | 000 |
| 10818788020946 | K051860 | 000 |
| 10818788020953 | K051860 | 000 |
| 10818788020960 | K051860 | 000 |
| 10818788020977 | K051860 | 000 |
| 10818788020984 | K051860 | 000 |
| 10818788020991 | K051860 | 000 |
| 10818788023695 | K051860 | 000 |