The following data is part of a premarket notification filed by Ingenious Technologies Corp. with the FDA for Needlesafe Ii & Needlegard Ii.
| Device ID | K936235 |
| 510k Number | K936235 |
| Device Name: | NEEDLESAFE II & NEEDLEGARD II |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | INGENIOUS TECHNOLOGIES CORP. 556 ROXBURY AVE., N.W. Massillon, OH 44646 -3281 |
| Contact | Edward D Lin |
| Correspondent | Edward D Lin INGENIOUS TECHNOLOGIES CORP. 556 ROXBURY AVE., N.W. Massillon, OH 44646 -3281 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-24 |
| Decision Date | 1994-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00725030550102 | K936235 | 000 |