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 |