The following data is part of a premarket notification filed by Macbrud Corp. Medical Div. with the FDA for Slip-pruf-clinger.
Device ID | K913049 |
510k Number | K913049 |
Device Name: | SLIP-PRUF-CLINGER |
Classification | Kit, Surgical Instrument, Disposable |
Applicant | MACBRUD CORP. MEDICAL DIV. 6280 SUNSET DRIVE #411 Miami, FL 33143 |
Contact | Banning G Lary |
Correspondent | Banning G Lary MACBRUD CORP. MEDICAL DIV. 6280 SUNSET DRIVE #411 Miami, FL 33143 |
Product Code | KDD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-09 |
Decision Date | 1991-09-11 |