The following data is part of a premarket notification filed by Kit Pak, Inc. with the FDA for Kit Pak Wet Saline Dressing.
Device ID | K942959 |
510k Number | K942959 |
Device Name: | KIT PAK WET SALINE DRESSING |
Classification | Dressing, Wound And Burn, Occlusive |
Applicant | KIT PAK, INC. 825 CHASE AVE. Elk Grove Village, IL 60007 |
Contact | Thomas J Sanders |
Correspondent | Thomas J Sanders KIT PAK, INC. 825 CHASE AVE. Elk Grove Village, IL 60007 |
Product Code | MGP |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-23 |
Decision Date | 1995-02-14 |