The following data is part of a premarket notification filed by Acuderm, Inc. with the FDA for Acu-micro-needle.
| Device ID | K874024 |
| 510k Number | K874024 |
| Device Name: | ACU-MICRO-NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | ACUDERM, INC. 5370 N.W. 35TH TERRACE Ft. Lauderdale, FL 33309 |
| Contact | Charles R Yeh |
| Correspondent | Charles R Yeh ACUDERM, INC. 5370 N.W. 35TH TERRACE Ft. Lauderdale, FL 33309 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-02 |
| Decision Date | 1987-11-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10814105020385 | K874024 | 000 |
| 00814105020371 | K874024 | 000 |
| 00814105020364 | K874024 | 000 |
| 00814105020357 | K874024 | 000 |
| 00814105020340 | K874024 | 000 |
| 00814105020333 | K874024 | 000 |
| 00814105020326 | K874024 | 000 |
| 00814105020319 | K874024 | 000 |
| 00814105020302 | K874024 | 000 |
| 00814105020296 | K874024 | 000 |
| 00814105020289 | K874024 | 000 |
| 00814105020272 | K874024 | 000 |
| 00814105020265 | K874024 | 000 |
| 00814105020258 | K874024 | 000 |
| 00814105020241 | K874024 | 000 |
| 00814105020234 | K874024 | 000 |
| 00814105020388 | K874024 | 000 |
| 10814105020224 | K874024 | 000 |
| 10814105020378 | K874024 | 000 |
| 10814105020361 | K874024 | 000 |
| 10814105020354 | K874024 | 000 |
| 10814105020347 | K874024 | 000 |
| 10814105020330 | K874024 | 000 |
| 10814105020323 | K874024 | 000 |
| 10814105020316 | K874024 | 000 |
| 10814105020309 | K874024 | 000 |
| 10814105020293 | K874024 | 000 |
| 10814105020286 | K874024 | 000 |
| 10814105020279 | K874024 | 000 |
| 10814105020262 | K874024 | 000 |
| 10814105020255 | K874024 | 000 |
| 10814105020248 | K874024 | 000 |
| 10814105020231 | K874024 | 000 |
| 00814105020227 | K874024 | 000 |