The following data is part of a premarket notification filed by Emerson-sack-warner Corp. with the FDA for Stand, Surg. Instrument & Dressing.
Device ID | K821921 |
510k Number | K821921 |
Device Name: | STAND, SURG. INSTRUMENT & DRESSING |
Classification | Tray, Surgical, Needle |
Applicant | EMERSON-SACK-WARNER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FSH |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-29 |
Decision Date | 1982-07-30 |