The following data is part of a premarket notification filed by Polymer Technology Corp. with the FDA for Empty Solution Transfer Container 1000.
| Device ID | K843523 |
| 510k Number | K843523 |
| Device Name: | EMPTY SOLUTION TRANSFER CONTAINER 1000 |
| Classification | Container, I.v. |
| Applicant | POLYMER TECHNOLOGY CORP. 369 NORTH NEWCOMB ST. Whitwater, WI 53190 |
| Contact | David D Plekenpol |
| Correspondent | David D Plekenpol POLYMER TECHNOLOGY CORP. 369 NORTH NEWCOMB ST. Whitwater, WI 53190 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-07 |
| Decision Date | 1984-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50812496011850 | K843523 | 000 |