The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Micro-arthroscope.
Device ID | K930084 |
510k Number | K930084 |
Device Name: | MICRO-ARTHROSCOPE |
Classification | Arthroscope |
Applicant | MEDICAL DEVICES, INC. 83 HOBART ST. Hackensack, NJ 07601 |
Contact | Samuel Dickstein |
Correspondent | Samuel Dickstein MEDICAL DEVICES, INC. 83 HOBART ST. Hackensack, NJ 07601 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-07 |
Decision Date | 1995-09-01 |