The following data is part of a premarket notification filed by Instafil, Inc. with the FDA for Modified Instafil.
| Device ID | K872446 |
| 510k Number | K872446 |
| Device Name: | MODIFIED INSTAFIL |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | INSTAFIL, INC. 17941 SKY PARK CIRCLE STE. E Irvine, CA 92714 |
| Contact | William W Sardam |
| Correspondent | William W Sardam INSTAFIL, INC. 17941 SKY PARK CIRCLE STE. E Irvine, CA 92714 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-23 |
| Decision Date | 1987-08-25 |