The following data is part of a premarket notification filed by D.j. Scott Mfg., Inc. with the FDA for Iv Comfort Pad.
Device ID | K930663 |
510k Number | K930663 |
Device Name: | IV COMFORT PAD |
Classification | Device, Intravascular Catheter Securement |
Applicant | D.J. SCOTT MFG., INC. 23102 TERRA DR. Laguna Hills, CA 92653 |
Contact | John R Smith |
Correspondent | John R Smith D.J. SCOTT MFG., INC. 23102 TERRA DR. Laguna Hills, CA 92653 |
Product Code | KMK |
CFR Regulation Number | 880.5210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-09 |
Decision Date | 1993-09-30 |