The following data is part of a premarket notification filed by Richard-allan Medical Ind., Inc. with the FDA for Protector (surgical Instrument).
Device ID | K890314 |
510k Number | K890314 |
Device Name: | PROTECTOR (SURGICAL INSTRUMENT) |
Classification | Container, Sharps |
Applicant | RICHARD-ALLAN MEDICAL IND., INC. 8850 M89 BOX 351 Richland, MI 49083 |
Contact | Nell Holdridge |
Correspondent | Nell Holdridge RICHARD-ALLAN MEDICAL IND., INC. 8850 M89 BOX 351 Richland, MI 49083 |
Product Code | MMK |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-23 |
Decision Date | 1989-02-27 |