The following data is part of a premarket notification filed by Micori Gifts, Inc. with the FDA for Petit Bands.
Device ID | K843587 |
510k Number | K843587 |
Device Name: | PETIT BANDS |
Classification | Tape And Bandage, Adhesive |
Applicant | MICORI GIFTS, INC. 624 SOUTH GRAND AVENUE Los Angeles , CA 90017 - |
Contact | Sherly E Stein |
Correspondent | Sherly E Stein MICORI GIFTS, INC. 624 SOUTH GRAND AVENUE Los Angeles , CA 90017 - |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-17 |
Decision Date | 1984-11-27 |