The following data is part of a premarket notification filed by Procedure Products, Inc. with the FDA for Insufflator Connecting Filter.
| Device ID | K923194 |
| 510k Number | K923194 |
| Device Name: | INSUFFLATOR CONNECTING FILTER |
| Classification | Insufflator, Laparoscopic |
| Applicant | PROCEDURE PRODUCTS, INC. 1801 WEST 4TH PLAIN BLVD. Vancouver, WA 98660 |
| Contact | Madalyn C Duncan |
| Correspondent | Madalyn C Duncan PROCEDURE PRODUCTS, INC. 1801 WEST 4TH PLAIN BLVD. Vancouver, WA 98660 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-30 |
| Decision Date | 1993-10-08 |