The following data is part of a premarket notification filed by Laboratories Delalande with the FDA for Inerpan(tm) Temporary Wound Dressing.
Device ID | K911161 |
510k Number | K911161 |
Device Name: | INERPAN(TM) TEMPORARY WOUND DRESSING |
Classification | Dressing, Wound And Burn, Occlusive |
Applicant | LABORATORIES DELALANDE SUITE 120 CANAL SQUARE 1054 31ST STREET, N.W. Washington, DC 20007 |
Contact | Jean-pierre Laclau |
Correspondent | Jean-pierre Laclau LABORATORIES DELALANDE SUITE 120 CANAL SQUARE 1054 31ST STREET, N.W. Washington, DC 20007 |
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 | 1991-03-15 |
Decision Date | 1991-06-27 |