The following data is part of a premarket notification filed by Mid-atlantic Diagnostics, Inc. with the FDA for The Stripper Pgd.
| Device ID | K041435 |
| 510k Number | K041435 |
| Device Name: | THE STRIPPER PGD |
| Classification | Microtools, Assisted Reproduction (pipettes) |
| Applicant | MID-ATLANTIC DIAGNOSTICS, INC. 438 NORTH ELMWOOD RD. Marlton, NJ 08053 |
| Contact | Susan J Bush |
| Correspondent | Susan J Bush MID-ATLANTIC DIAGNOSTICS, INC. 438 NORTH ELMWOOD RD. Marlton, NJ 08053 |
| Product Code | MQH |
| CFR Regulation Number | 884.6130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-28 |
| Decision Date | 2004-09-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937907814 | K041435 | 000 |
| 00888937907940 | K041435 | 000 |
| 00888937907933 | K041435 | 000 |
| 00888937907834 | K041435 | 000 |