The following data is part of a premarket notification filed by Innovative Medical Manufacturing Co. with the FDA for Imm Hypodermic Needle Set.
| Device ID | K070801 |
| 510k Number | K070801 |
| Device Name: | IMM HYPODERMIC NEEDLE SET |
| Classification | Set, Administration, Intravascular |
| Applicant | INNOVATIVE MEDICAL MANUFACTURING CO. 7128 STAFFORDSHIRE ST. Houston, TX 77030 |
| Contact | Joseph J Chang |
| Correspondent | Joseph J Chang INNOVATIVE MEDICAL MANUFACTURING CO. 7128 STAFFORDSHIRE ST. Houston, TX 77030 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-23 |
| Decision Date | 2007-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10193493985910 | K070801 | 000 |
| 10193493924209 | K070801 | 000 |
| 10193493924193 | K070801 | 000 |
| 10193493924162 | K070801 | 000 |