The following data is part of a premarket notification filed by Sandal Surgico with the FDA for Percussion Hammer.
Device ID | K891571 |
510k Number | K891571 |
Device Name: | PERCUSSION HAMMER |
Classification | Percussor |
Applicant | SANDAL SURGICO INDUSTRIAL ESTATE P.O. BOX NO. 224 Sialkot, PK |
Contact | A. Q Sandal |
Correspondent | A. Q Sandal SANDAL SURGICO INDUSTRIAL ESTATE P.O. BOX NO. 224 Sialkot, PK |
Product Code | GWZ |
CFR Regulation Number | 882.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-20 |
Decision Date | 1989-03-31 |