The following data is part of a premarket notification filed by Angiplast Private Ltd. with the FDA for Angeltouch Vented Iv Administration Set.
| Device ID | K012189 |
| 510k Number | K012189 |
| Device Name: | ANGELTOUCH VENTED IV ADMINISTRATION SET |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | ANGIPLAST PRIVATE LTD. 4803, PHASE IV, G.I.D.C., VATVA Ahmedabad, IN 382 445 |
| Contact | Ashit B Shah |
| Correspondent | Ashit B Shah ANGIPLAST PRIVATE LTD. 4803, PHASE IV, G.I.D.C., VATVA Ahmedabad, IN 382 445 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-12 |
| Decision Date | 2002-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784706238 | K012189 | 000 |
| 00616784703138 | K012189 | 000 |
| 00616784703237 | K012189 | 000 |
| 00616784703336 | K012189 | 000 |
| 00616784703435 | K012189 | 000 |
| 00616784703534 | K012189 | 000 |
| 00616784703633 | K012189 | 000 |
| 00616784703732 | K012189 | 000 |
| 00616784704838 | K012189 | 000 |
| 00616784704937 | K012189 | 000 |
| 00616784705033 | K012189 | 000 |
| 00616784705132 | K012189 | 000 |
| 00616784705231 | K012189 | 000 |
| 00616784705330 | K012189 | 000 |
| 00616784705439 | K012189 | 000 |
| 00616784706030 | K012189 | 000 |
| 00616784706139 | K012189 | 000 |
| 00616784703039 | K012189 | 000 |