The following data is part of a premarket notification filed by Apple Medical Corp. with the FDA for Apple Medical One-touch Uterine Sampler.
| Device ID | K000026 |
| 510k Number | K000026 |
| Device Name: | APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| Applicant | APPLE MEDICAL CORP. 28 LORD RD., UNIT 135 Marlboro, MA 01752 |
| Contact | John Pulford |
| Correspondent | John Pulford APPLE MEDICAL CORP. 28 LORD RD., UNIT 135 Marlboro, MA 01752 |
| Product Code | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-05 |
| Decision Date | 2000-03-31 |