The following data is part of a premarket notification filed by Procedure Products, Inc. with the FDA for Bag Spigot.
| Device ID | K910673 |
| 510k Number | K910673 |
| Device Name: | BAG SPIGOT |
| Classification | Container, I.v. |
| Applicant | PROCEDURE PRODUCTS, INC. 1801 WEST 4TH PLAIN BLVD. Vancouver, WA 98660 |
| Contact | Bob Everett |
| Correspondent | Bob Everett PROCEDURE PRODUCTS, INC. 1801 WEST 4TH PLAIN BLVD. Vancouver, WA 98660 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-15 |
| Decision Date | 1991-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B160477221 | K910673 | 000 |
| B16047101 | K910673 | 000 |