The following data is part of a premarket notification filed by Medi-tech Intl. Corp. with the FDA for Spand-gel Granulated Gel.
Device ID | K864124 |
510k Number | K864124 |
Device Name: | SPAND-GEL GRANULATED GEL |
Classification | Bandage, Liquid |
Applicant | MEDI-TECH INTL. CORP. 26 COURT ST. Brooklyn, NY 11242 |
Contact | Herbert A Perry |
Correspondent | Herbert A Perry MEDI-TECH INTL. CORP. 26 COURT ST. Brooklyn, NY 11242 |
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 | 1986-10-21 |
Decision Date | 1986-11-26 |