The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Slicktip Solid Laparoscopic Electrode, Models Lh01z, Lb02z, Ln03z, Lc04z, Ls05z, Ll06z, Lj07z.
Device ID | K984239 |
510k Number | K984239 |
Device Name: | SLICKTIP SOLID LAPAROSCOPIC ELECTRODE, MODELS LH01Z, LB02Z, LN03Z, LC04Z, LS05Z, LL06Z, LJ07Z |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 -2902 |
Contact | J. Robert Saron |
Correspondent | J. Robert Saron AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 -2902 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-27 |
Decision Date | 1999-02-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10889942583331 | K984239 | 000 |
10889942583041 | K984239 | 000 |
10889942583119 | K984239 | 000 |
10889942583126 | K984239 | 000 |
10889942583133 | K984239 | 000 |
10889942583140 | K984239 | 000 |
10889942583157 | K984239 | 000 |
10889942583164 | K984239 | 000 |
10889942583188 | K984239 | 000 |
10889942583195 | K984239 | 000 |
10889942583300 | K984239 | 000 |
10889942583317 | K984239 | 000 |
10889942542109 | K984239 | 000 |