The following data is part of a premarket notification filed by Hunter Scientific Limited with the FDA for Hunter Scientific Injection Pipettes.
| Device ID | K001615 |
| 510k Number | K001615 |
| Device Name: | HUNTER SCIENTIFIC INJECTION PIPETTES |
| Classification | Microtools, Assisted Reproduction (pipettes) |
| Applicant | HUNTER SCIENTIFIC LIMITED UNIT 1, PRIORS HALL, WIDDINGTON Saffron Walden, Essex, GB Cb113sb |
| Contact | Mark Rawe |
| Correspondent | Mark Rawe HUNTER SCIENTIFIC LIMITED UNIT 1, PRIORS HALL, WIDDINGTON Saffron Walden, Essex, GB Cb113sb |
| Product Code | MQH |
| CFR Regulation Number | 884.6130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-25 |
| Decision Date | 2000-08-18 |