The following data is part of a premarket notification filed by Scott Health Care with the FDA for Promise Absorbent Protective Pad.
Device ID | K900421 |
510k Number | K900421 |
Device Name: | PROMISE ABSORBENT PROTECTIVE PAD |
Classification | Pad, Menstrual, Unscented |
Applicant | SCOTT HEALTH CARE SCOTT PLAZA III Philadelphia, PA 19113 -1585 |
Contact | Richard A Hamer |
Correspondent | Richard A Hamer SCOTT HEALTH CARE SCOTT PLAZA III Philadelphia, PA 19113 -1585 |
Product Code | HHD |
CFR Regulation Number | 884.5435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-30 |
Decision Date | 1990-06-06 |