The following data is part of a premarket notification filed by Ace Medical Co. with the FDA for Ace Pelvic Stabilizer.
| Device ID | K933968 |
| 510k Number | K933968 |
| Device Name: | ACE PELVIC STABILIZER |
| Classification | Component, Traction, Invasive |
| Applicant | ACE MEDICAL CO. 14105 SOUTH AVALON BLVD. Los Angeles, CA 90061 |
| Contact | Claud O Pering |
| Correspondent | Claud O Pering ACE MEDICAL CO. 14105 SOUTH AVALON BLVD. Los Angeles, CA 90061 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-16 |
| Decision Date | 1994-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868001406 | K933968 | 000 |
| 00887868076954 | K933968 | 000 |