The following data is part of a premarket notification filed by Irvine Scientific Sales Co., Inc. with the FDA for Water For Assisted Reproductive Technologies (a.r.t.) Use.
| Device ID | K011598 |
| 510k Number | K011598 |
| Device Name: | WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE |
| Classification | System, Water, Reproduction, Assisted, And Purification |
| Applicant | IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Contact | Wendell Lee |
| Correspondent | Wendell Lee IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Product Code | MTW |
| CFR Regulation Number | 884.6170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-24 |
| Decision Date | 2001-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857515006078 | K011598 | 000 |