The following data is part of a premarket notification filed by Epimed International, Inc. with the FDA for Extension Set, Models 1911-512.
| Device ID | K020926 |
| 510k Number | K020926 |
| Device Name: | EXTENSION SET, MODELS 1911-512 |
| Classification | Set, Administration, Intravascular |
| Applicant | EPIMED INTERNATIONAL, INC. 141 SAL LANDRIO DR. CROSSROADS BUSINESS PARK Johnstown, NY 12095 |
| Contact | Christopher B Lake |
| Correspondent | Christopher B Lake EPIMED INTERNATIONAL, INC. 141 SAL LANDRIO DR. CROSSROADS BUSINESS PARK Johnstown, NY 12095 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-21 |
| Decision Date | 2002-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818788021608 | K020926 | 000 |
| 10818788021592 | K020926 | 000 |
| 10818788021585 | K020926 | 000 |