The following data is part of a premarket notification filed by Marketing Perspectives with the FDA for Perspectives Impregnated Hydrogel Wound Dressing.
Device ID | K953669 |
510k Number | K953669 |
Device Name: | PERSPECTIVES IMPREGNATED HYDROGEL WOUND DRESSING |
Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
Applicant | MARKETING PERSPECTIVES 4405 NASHWOOD LN. Dallas, TX 75244 |
Contact | Pat Lamb |
Correspondent | Pat Lamb MARKETING PERSPECTIVES 4405 NASHWOOD LN. Dallas, TX 75244 |
Product Code | MGQ |
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 | 1995-08-07 |
Decision Date | 1995-09-22 |