The following data is part of a premarket notification filed by Imed Corp. with the FDA for Administration Sets With Ball Float.
| Device ID | K951922 |
| 510k Number | K951922 |
| Device Name: | ADMINISTRATION SETS WITH BALL FLOAT |
| Classification | Set, Administration, Intravascular |
| Applicant | IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699 |
| Contact | Ahmad Sajadi |
| Correspondent | Ahmad Sajadi IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-24 |
| Decision Date | 1995-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885403235083 | K951922 | 000 |
| 50885403235007 | K951922 | 000 |
| 50885403233744 | K951922 | 000 |
| 50885403232235 | K951922 | 000 |
| 37613203021402 | K951922 | 000 |