The following data is part of a premarket notification filed by Spenco Medical Corp. with the FDA for Spenco Breast Forms.
| Device ID | K896533 |
| 510k Number | K896533 |
| Device Name: | SPENCO BREAST FORMS |
| Classification | Prosthesis, Breast, External, Used With Adhesive |
| Applicant | SPENCO MEDICAL CORP. P.O. BOX 2501 Waco, TX 76702 |
| Contact | James E Mcgowan |
| Correspondent | James E Mcgowan SPENCO MEDICAL CORP. P.O. BOX 2501 Waco, TX 76702 |
| Product Code | KCZ |
| CFR Regulation Number | 878.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-14 |
| Decision Date | 1989-12-13 |