The following data is part of a premarket notification filed by Deep Trading Corp. with the FDA for Oolitt Tongue Cleaner, Regular Low Ripple/special High Ripple/low Ripple Double/high & Low Ripple/comfort Eze.
| Device ID | K962941 |
| 510k Number | K962941 |
| Device Name: | OOLITT TONGUE CLEANER, REGULAR LOW RIPPLE/SPECIAL HIGH RIPPLE/LOW RIPPLE DOUBLE/HIGH & LOW RIPPLE/COMFORT EZE |
| Classification | Scraper, Tongue |
| Applicant | DEEP TRADING CORP. 2906 WHITTINGTON PL. Tampa, FL 33618 |
| Contact | D. Patel |
| Correspondent | D. Patel DEEP TRADING CORP. 2906 WHITTINGTON PL. Tampa, FL 33618 |
| Product Code | LCN |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-29 |
| Decision Date | 1996-10-08 |