The following data is part of a premarket notification filed by Calgon Corp. with the FDA for Kaltogel Wound Dressing.
| Device ID | K940407 |
| 510k Number | K940407 |
| Device Name: | KALTOGEL WOUND DRESSING |
| Classification | Bandage, Liquid |
| Applicant | CALGON CORP. SUB. MERCK & CO., INC. 5035 MANCHESTER AVE. St. Louis, MO 63110 |
| Contact | Anne Schmitt |
| Correspondent | Anne Schmitt CALGON CORP. SUB. MERCK & CO., INC. 5035 MANCHESTER AVE. St. Louis, MO 63110 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-27 |
| Decision Date | 1994-04-07 |