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 |